MEDIA

Biosimilar Development Must Rely on Science to Realize Patient Access and Savings, Biosimilars Council Urges FDA Arthritis Advisory Committee

Contact: Steve Arnoff 202.249.7113

WASHINGTON, DC (July 12, 2016) — Patient access to biosimilars will hinge on critical policy decisions around extrapolation and biosimilar label content, asserts the Biosimilars Council, a division of the Generic Pharmaceutical Association (GPhA) in comments to the Food and Drug Administration (FDA) Arthritis Advisory Committee.

Christine Simmon, Senior Vice President, GPhA, and Executive Director, Biosimilars Council, is presenting LINK in two public meetings on July 12-13 to the FDA Advisory Committee which is convening to discuss pending applications for two rheumatoid arthritis biosimilars.

“The Biosimilars Council commends the FDA’s work toward creating a regulatory environment that maximizes patient access to biosimilars,” said Simmon. “The Council is confident in the FDA’s robust and rigorous scientific approach to biosimilars and applauds the agency’s efforts to educate providers and patients so they can be confident in these medicines and access them at a lower cost.”

However, the Biosimilars Council believes that requiring a statement of biosimilarity on the product label, as proposed in FDA guidance, is unnecessary. The Council also supports extrapolation of data to confirm safety and efficacy.
Simmon states:

“Including a biosimilar product’s biosimilarity data in addition to that of the reference product would only provide unnecessary information and create confusion for prescribers and patients. This differentiation between biosimilars and their reference products risks undermining the important provider education that is being done by the FDA today. Informing providers that ‘biosimilars have no clinically meaningful differences in terms of safety, purity and potency (safety and effectiveness) from the reference product,’ while requiring a differentiator in the labeling sends mixed signals to providers responsible for driving patient familiarity and comfort with these products.

…FDA has used comparability, or extrapolation of information, for nearly 20 years. In such cases, clinical data are typically provided to confirm safety and efficacy of one indication and, taking into account the totality of information gained from the comparability exercise. Based on the acceptable outcome of the comparability and clinical evaluations, the data may then be extrapolated to the other indications.”

“Policy decisions must be grounded in the reliable science used to develop these medicines. Decisions made now will create the market dynamic ultimately responsible for putting biosimilars and their savings within reach for millions of American patients,” said Simmon.

View the comments here.

 

About the GPhA Biosimilars Council

The Biosimilars Council, a division of the Generic Pharmaceutical Association (GPhA), works to ensure a positive environment for patient access to biosimilar medicines. The Biosimilars Council is a leading source for information about the safety and efficacy of more affordable alternatives to costly brand biologic medicines. Areas of focus include public and health expert education, strategic partnerships, government affairs, legal affairs and regulatory policy. More information is available at www.biosimilarscouncil.org.

About GPhA

GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals fill 88 percent of the prescriptions dispensed in the U.S. but consume just 28 percent of the total drug spending. Additional information is available at gphaonline.org. Follow us on twitter: @gpha.

 

GPhA Welcomes Senate Hearing to Examine REMS Abuse by Certain Brand Drug Companies, Identify Ways to Boost Patient Access to Affordable Medicines

Contact: Steve Arnoff 202.249.7113

WASHINGTON, DC (June 21, 2016) — The Generic Pharmaceutical Association (GPhA) welcomed today’s Senate Judiciary Subcommittee on Antitrust, Competition Policy and Consumer Rights hearing, The CREATES Act: Ending Regulatory Abuse, Protecting Consumers, and Ensuring Drug Price Competition. The hearing focused on provisions in the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act that help stop misuse of Food and Drug Administration (FDA) Risk Evaluation and Mitigation (REMS) programs and certain brand drug companies’ voluntary adoption of similar restrictions despite the lack of any FDA mandate. Experts note that these manipulations block generic and biosimilar competition, limit patient access and lead to higher drug prices.

GPhA member Beth Zelnick Kaufman, Assistant General Counsel, Amneal Pharmaceuticals, testified at today’s hearing. She said:

“The CREATES Act provides essential relief and remedies when brand companies refuse to provide samples on commercially reasonable terms or drag their feet during shared REMS negotiations. It will help make the promise of affordable medicine a reality for more Americans.”

Zelnick Kaufman’s full testimony is available here.

“The CREATES Act is a bipartisan solution to stop REMS abuse and limit similar restrictions that certain branded drug makers use to limit competition,” said Chip Davis, President and CEO, GPhA. “GPhA is pleased that the Senate is choosing to shine a light on brand drug company ploys to block patient access to safe, effective and more affordable generic and biosimilar medicines. A diverse group of health experts, providers, stakeholders, economists, regulators and others recognize that a legislative remedy is needed to stop REMS abuse and encourages swift passage of the CREATES Act.”

The CREATES Act (S. 3056) was introduced last week by Senate Judiciary Committee Chairman Chuck Grassley (R-IA), Ranking Member Patrick Leahy (D-VT), and Antitrust, Competition Policy & Consumer Rights Subcommittee Chairman Mike Lee (R-UT) and Ranking Member Amy Klobuchar (D-MN).

Visit www.stopREMSabuse.com for more information on GPhA efforts to enhance patient access to safe and more affordable medicines.

Resources:
The CREATES Act (full) (summary)
CREATES Act stakeholder support letter
Lost Prescription Drug Savings from Use of REMS Programs to Delay Generic Market Entry 
The Hill: Strengthening REMS for Patient Safety, Faster Access to Generics
AP: Drug Distribution Becomes Weapon to Block Competition

 

About the GPhA Biosimilars Council

The Biosimilars Council, a division of the Generic Pharmaceutical Association (GPhA), works to ensure a positive environment for patient access to biosimilar medicines. The Biosimilars Council is a leading source for information about the safety and efficacy of more affordable alternatives to costly brand biologic medicines. Areas of focus include public and health expert education, strategic partnerships, government affairs, legal affairs and regulatory policy. More information is available at www.biosimilarscouncil.org.

About GPhA

GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals fill 88 percent of the prescriptions dispensed in the U.S. but consume just 28 percent of the total drug spending. Additional information is available at gphaonline.org. Follow us on twitter: @gpha.

 

GPhA, Major Health Stakeholders Support New Senate Judiciary Bill to Curb REMS Abuse

Contact: Steve Arnoff 202.249.7113

CREATES Act Promotes Pharmaceutical Competition, Helps Expand Patient Access to Affordable Medicines

WASHINGTON, DC (June 14, 2016) — The Generic Pharmaceutical Association (GPhA) supports today’s introduction of the Creating and Restoring Equal Access to Equivalent Samples (“CREATES”) Act by Senate Judiciary Committee Chairman Chuck Grassley (R-IA), Ranking Member Patrick Leahy (D-VT), and Antitrust, Competition Policy & Consumer Rights Subcommittee Chairman Mike Lee (R-UT) and Ranking Member Amy Klobuchar (D-MN).

The CREATES Act improves patient access to safe and affordable medicines by taking steps to curb abuses of Risk Evaluation and Mitigation Strategies (REMS) without compromising patient safety.

“GPhA is committed to improving access to safe, effective and affordable generic and biosimilar medicines for millions of patients. We continue to advocate for common sense reforms that enhance patient access, increase competition and lower health costs,” said Chip Davis, President and CEO, GPhA. “It is worth noting and recognizing recent efforts by representatives in the branded industry to highlight the valuable role generic medicines play in driving healthcare system savings, including their support for reducing the backlog of pending ANDA applications at the FDA. However, continued use of these anticompetitive practices by certain manufacturers drives the exact opposite outcome; delaying or eliminating alternative treatment options to advance patient outcomes while continuing to increase healthcare costs. It is time to put a stop to these anticompetitive maneuvers.”

REMS are Food and Drug Administration (FDA) programs designed to protect patient safety, but certain brand drug companies misuse them to block competition from generic medicines. Matrix Global Advisors analysis found that abuse of programs like REMS costs the health care system $5.4 billion annually. Further, if the practice of misusing REMS programs expands to biosimilars as they begin to enter the U.S. healthcare system, Matrix notes that it could result in approximately $140 million in additional lost savings for every $1 billion in biologics sales.

A group of 15 major healthcare stakeholders wrote a letter to welcome the bipartisan introduction of the CREATES Act and applauded the leadership of its sponsors:

“Companies that exploit restricted access programs – whether under the pretext of an FDA-mandate or on their own accord - delay generic competition and undermine the intent of Hatch-Waxman at the expense of America’s patients. The CREATES Act is a common sense solution that will prevent such abuses, and further patient access to safe, effective, and affordable medications. We thank you again for your incredible efforts in introducing this bill.”

REMS abuse can occur in two scenarios. First, when a brand drug company refuses to sell samples of its product to potential generic competitors, a ploy that prevents the generic company from conducting bioequivalence tests necessary to gain FDA approval and provide patients and their providers more affordable treatment options. Second, when a brand drug company intentionally prevents generic competitors from joining a “shared REMS,” a distribution protocol applicable to both brand and generic versions of the medicine. This tactic also has the effect of keeping generic competitors off the market, even at times when the brand drug patent is past expiration.

The CREATES Act addresses these scenarios by authorizing a judge to award damages to deter future misconduct. The bill allows a generic drug manufacturer to bring an action in federal court to obtain the sample it needs, authorizes a judge to award damages to deter future misconduct and allows brands and generics to enter court-supervised negotiations for establishing shared safety protocol. The bill also helps deter misuse among brand manufacturers with self-imposed (not required by FDA) REMS-like restrictions on the sale or distribution of products.

“GPhA and the Biosimilars Council strongly support FDA-mandated REMS programs. These critical patient safety programs serve a public health good and should be strengthened so that they are used as intended,” said Davis. “As experts continue to point to unsustainable brand and specialty drug costs, the CREATES Act takes needed steps needed to stop brand drug company REMS abuses.

At a time when everyone is looking for ways to lower health costs, the CREATES Act takes a clear bipartisan stand in favor of pharmaceutical competition, patient access and patient savings from safe, effective and more affordable generic and biosimilar medicines.”

Visit www.StopREMSAbuse.org for more information.

Resources:
The CREATES Act (full) (summary)
CREATES Act group letter
Lost Prescription Drug Savings from Use of REMS Programs to Delay Generic Market Entry
The Hill: Strengthening REMS for Patient Safety, Faster Access to Generics
AP: Drug Distribution Becomes Weapon to Block Competition

 

About the GPhA Biosimilars Council

The Biosimilars Council, a division of the Generic Pharmaceutical Association (GPhA), works to ensure a positive environment for patient access to biosimilar medicines. The Biosimilars Council is a leading source for information about the safety and efficacy of more affordable alternatives to costly brand biologic medicines. Areas of focus include public and health expert education, strategic partnerships, government affairs, legal affairs and regulatory policy. More information is available at www.biosimilarscouncil.org.

About GPhA

GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals fill 88 percent of the prescriptions dispensed in the U.S. but consume just 28 percent of the total drug spending. Additional information is available at gphaonline.org. Follow us on twitter: @gpha.

 

Healthcare Stakeholders Call On FDA to Support Patient Access to Biosimilars by Avoiding Unnecessary Labeling Statements

Contact: Steve Arnoff 202.249.7113

WASHINGTON, DC (June 3, 2016) — To ensure patient access to newer, more affordable versions of biologic medicines, the Food and Drug Administration (FDA) should avoid requiring a statement of biosimilarity on the product label, a group of leading pharmaceutical supply chain organizations stated in a letter submitted to the agency today. The 11 signatories support biosimilar labeling that will lead to the increased access and cost-saving promise of biosimilars, also articulated in the Generic Pharmaceutical Association (GPhA) and its Biosimilars Council’s comments submitted to FDA.

“We applaud the agency’s efforts to educate providers about biosimilars. However, a statement of biosimilarity on the label is unnecessary and could put biosimilar utilization and savings at risk,” said Chip Davis, President and CEO, GPhA. “To date, we are not aware that FDA has provided sufficient justification for its inclusion in biosimilar labeling. Unwarranted differentiation between biosimilars and their reference products can undermine provider and patient education efforts as biosimilar products become available for the first time to millions of U.S. patients.”

The letter’s 11 signatories include: Academy of Managed Care Pharmacy (AMCP), America’s Health Insurance Plans (AHIP), American Pharmacists Association (APhA), Blue Cross Blue Shield Association (BCBSA), CVS Health, Express Scripts, Healthcare Supply Chain Association (HSCA),
Pharmaceutical Care Management Association (PCMA), Premier healthcare alliance, Prime Therapeutics and UAW Retiree Medical Benefits.

The letter states:

In most cases, the scientific information necessary to approve a biosimilar will primarily focus on establishing biosimilarity between the two products. This means that safety and efficacy information will come from studies of the reference product rather than the biosimilar. Including a biosimilar product’s biosimilarity data in addition to that of the reference product would only provide unnecessary information and create confusion for prescribers and patients.

This differentiation between biosimilars and their reference products risks undermining the important provider education that is being done by the FDA today. Informing providers that “biosimilars have no clinically meaningful differences in terms of safety, purity and potency (safety and effectiveness) from the reference product” while requiring a differentiator on the labeling sends mixed signals to providers responsible for driving patient familiarity and comfort with these products.

Read the full letter here.
Read the GPhA Biosimilars Council comments to FDA here.

 

About the GPhA Biosimilars Council

The Biosimilars Council, a division of the Generic Pharmaceutical Association (GPhA), works to ensure a positive environment for patient access to biosimilar medicines. The Biosimilars Council is a leading source for information about the safety and efficacy of more affordable alternatives to costly brand biologic medicines. Areas of focus include public and health expert education, strategic partnerships, government affairs, legal affairs and regulatory policy. More information is available at www.biosimilarscouncil.org.

About GPhA

GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals fill 88 percent of the prescriptions dispensed in the U.S. but consume just 28 percent of the total drug spending. Additional information is available at gphaonline.org. Follow us on twitter: @gpha.

 

GPhA Biosimilars Council Concerned CMS Part B Demo Could Limit
Biosimilar Competition

Contact: Steve Arnoff 202.249.7113

WASHINGTON, DC (May 9, 2016) — The Generic Pharmaceutical Association (GPhA) and its Biosimilars Council are concerned that the Centers for Medicare and Medicaid Services (CMS) proposed demonstration to revamp how Part B pays for prescription drugs will “erode the economic incentives that drive the U.S. healthcare system to lower-cost therapeutic alternatives,” particularly in the biosimilars space, according to comments submitted to CMS today. GPhA and its Biosimilars Council also urge the agency to rethink its proposal to avoid adoption of value-based tools that undermine the balance between competition and innovation.

In the comments, Christine Simmon, Senior Vice President, Policy and Strategic Alliances, GPhA, states:

“Both GPhA and the Biosimilars Council share CMS’ stated goal of reducing overall Medicare expenditures, while maintaining or improving the quality of care provided to beneficiaries. Generic prescription drugs and biosimilars are uniquely positioned to help CMS achieve this goal.

However, we have serious concerns that the demonstration, as proposed, risks limiting the savings created through open market competition, particularly in the nascent biosimilars market. We strongly encourage the agency to carefully consider thoughtful changes to both phases of the demonstration in order to maintain robust competition, and a strong incentive to invest in affordable medicine, where possible.

Most importantly, CMS should ensure that Phase II of the proposal does not create an environment where generic or biosimilar products are compared with anything other than their intended reference product.”

GPhA and the Biosimilars Council also continue to oppose CMS’ coding and payment policy for non-interchangeable biosimilars, as outlined in 2015 public comments. The current coding and Average Sales Price (ASP) calculation methods are a significant departure from previous CMS policy and unfairly disadvantage non-interchangeable biosimilars.

Additionally, GPhA and the Biosimilars Council also voiced some concern over the expansive scope of the proposal, and urged CMS to consider a more targeted demonstration that could more effectively measure the effects of any new Value-Based proposals.

“Generic drugs and biosimilars can play a significant role in CMS efforts to lower health costs,” said Simmon. “We look forward to working with CMS to expand beneficiary access to more affordable alternatives to high-cost products.”

Read the full comments here.

 

About the GPhA Biosimilars Council

The Biosimilars Council, a division of the Generic Pharmaceutical Association (GPhA), works to ensure a positive environment for patient access to biosimilar medicines. The Biosimilars Council is a leading source for information about the safety and efficacy of more affordable alternatives to costly brand biologic medicines. Areas of focus include public and health expert education, strategic partnerships, government affairs, legal affairs and regulatory policy. More information is available at www.biosimilarscouncil.org.

About GPhA

GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals fill 88 percent of the prescriptions dispensed in the U.S. but consume just 28 percent of the total drug spending. Additional information is available at gphaonline.org. Follow us on twitter: @gpha.

 

Statement by David Gaugh, Senior Vice President, Sciences and Regulatory Affairs, Regarding the USTR Special 301 Report

Contact: Steve Arnoff 202.249.7113

WASHINGTON, DC (May 2, 2016) — "The Generic Pharmaceutical Association (GPhA) and its Biosimilars Council strongly support intellectual property (IP) policies that undergird balanced systems — those that promote innovation while ensuring expedited access to affordable medicines. However, the industry remains concerned that elements of the United States Trade Representative (USTR) Special 301 Report could limit competition from safe and effective generic drugs and biosimilars.

“GPhA and its Biosimilars Council are hopeful that USTR recognizes that some Special 301 Report findings could lead countries to expand intellectual property protections beyond existing global convention, an effort that would create new barriers to trade and hinder U.S. generic drug and biosimilar exporting,” said David Gaugh, Senior Vice President, Sciences and Regulatory Affairs, GPhA. “It is especially important that the Special 301 Report findings do not lead countries to adopt overprotective IP standards that go well beyond those set in the Trade Related Aspects of Intellectual Property Rights (TRIPs) Agreement.

The Special 301 Report identification of countries that could adopt more balanced IP provisions is beneficial; however a more transparent process is needed. GPhA urges the U.S. Trade Representative (USTR) to utilize more objective criteria in its Special 301 Report to identify countries that do not provide ‘adequate and effective intellectual property rights.’ Such criteria could be based on the failure of countries to comply with TRIPs obligations and/or in bilateral and regional agreements entered into by those countries.

Moreover, while the report affirms that TRIPS grants trading partners sufficient flexibility to address public health challenges while maintaining IP standards that promote innovation, it continues to single out countries for utilizing some of those flexibilities. As such, we are concerned that the report raises undue concern against the use of TRIPs flexibilities, particularly in the case of compulsory licensing.

GPhA supports USTR efforts to encourage a more predictable IP framework that can give companies ample time for market planning and other business decisions. These efforts are particularly important as the U.S. biosimilars industry takes shape. The association and its members look forward to working with USTR and others to ensure an objective, consistent and balanced global IP standard that promotes competition from safe, effective and more affordable generics and biosimilars."

 

About the GPhA Biosimilars Council

The Biosimilars Council, a division of the Generic Pharmaceutical Association (GPhA), works to ensure a positive environment for patient access to biosimilar medicines. The Biosimilars Council is a leading source for information about the safety and efficacy of more affordable alternatives to costly brand biologic medicines. Areas of focus include public and health expert education, strategic partnerships, government affairs, legal affairs and regulatory policy. More information is available at www.biosimilarscouncil.org.

About GPhA

GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals fill 88 percent of the prescriptions dispensed in the U.S. but consume just 28 percent of the total drug spending. Additional information is available at gphaonline.org. Follow us on twitter: @gpha.

 

Statement by Chip Davis, President and CEO, GPhA, Regarding FDA Draft Guidance on Biosimilar Labeling

Contact: Steve Arnoff 202.249.7113

WASHINGTON, DC (April 1, 2016) — "The Generic Pharmaceutical Association and its Biosimilars Council are pleased that the Food and Drug Administration (FDA) has issued its draft guidance on biosimilar labeling. This draft guidance provides manufacturers with additional clarity needed to manufacture and distribute more affordable versions of biologic medicines for patients.

The Council is pleased that the FDA guidance takes steps to avoid confusion and in many aspects, mirrors the protocol for labeling of generic drugs. For example, a statement defining biosimilarity would be included rather than lengthy and already established scientific data proving biosimilarity. And, immunogenicity details would mirror the label content of the reference product.

GPhA and the Council are especially pleased that the proposed label contents avoid causing confusion or raising unnecessary questions about the safety and efficacy of biosimilar products. FDA recognizes that approved biosimilars meet all agency safety and efficacy standards. The draft requirements would ensure that the label reflects these core principles and provides concise, factual information. The draft guidance is a positive step to assure patients, providers and others that these products are just as safe and effective as their brand biologic counterparts. We also commend the agency for postponing guidance on interchangeable biologic labeling at this time.

GPhA and the Biosimilars Council plan to provide an expanded perspective within the FDA comment period for this guidance and look forward to working with the Agency on other outstanding biosimilar guidances."

 

About the GPhA Biosimilars Council

The Biosimilars Council, a division of the Generic Pharmaceutical Association (GPhA), works to ensure a positive environment for patient access to biosimilar medicines. The Biosimilars Council is a leading source for information about the safety and efficacy of more affordable alternatives to costly brand biologic medicines. Areas of focus include public and health expert education, strategic partnerships, government affairs, legal affairs and regulatory policy. More information is available at www.biosimilarscouncil.org.

About GPhA

GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals fill 88 percent of the prescriptions dispensed in the U.S. but consume just 28 percent of the total drug spending. Additional information is available at gphaonline.org. Follow us on twitter: @gpha.

 

GPhA and its Biosimilars Council Applaud IGBA Call for WHO Biologic Qualifier Impact Assessment

Contact: Steve Arnoff 202.249.7113

WASHINGTON, DC (March 2, 2016)

Statement by Chip Davis, President and CEO, GPhA:

“The Generic Pharmaceutical Association (GPhA) and its Biosimilars Council applaud the International Generic and Biosimilar medicines Association (IGBA) for urging the World Health Organization (WHO) to conduct an international impact assessment of the voluntary biologic qualifier (BQ) proposal on biologic product access, quality and safety.

The Biosimilars Council does not support the addition of a random BQ assigned to the international nonproprietary name (INN) for biologics and shares the IGBA concern that WHO will need more time to properly assess the global implications of its BQ proposal.

The Council urges WHO to extend the timeline for this impact assessment in order to fully ascertain the range of concerns regarding implementation of the BQ approach including its questionable underlying rationale, uncertain retrospective application, and potential to limit competition and undermine provider confidence in safe and effective biosimilar products.

Tracking and safety concerns have long been addressed by the inclusion on the label of the brand name, company name, national drug code (NDC) and lot number, thus, eliminating the need for unnecessarily complicated and confusing suffixes or checksums — there is no compelling reason to add additional identifiers for biosimilar drugs.

Since the WHO guidelines are optional for each country’s respective regulatory authority, the Biosimilars Council believes the focus should be placed on the Food and Drug Administration’s (FDA’s) review of public comments received on its draft guidance on naming. The Council will continue working with domestic and international regulatory bodies to finalize regulations that promote pharmaceutical competition, enable access and increase savings for millions of patients.”

Read the IGBA release here.

 

About the GPhA Biosimilars Council

The Biosimilars Council, a division of the Generic Pharmaceutical Association (GPhA), works to ensure a positive environment for patient access to biosimilar medicines. The Biosimilars Council is a leading source for information about the safety and efficacy of more affordable alternatives to costly brand biologic medicines. Areas of focus include public and health expert education, strategic partnerships, government affairs, legal affairs and regulatory policy. More information is available at www.biosimilarscouncil.org.

About GPhA

GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals fill 88 percent of the prescriptions dispensed in the U.S. but consume just 28 percent of the total drug spending. Additional information is available at gphaonline.org. Follow us on twitter: @gpha.

 

Biosimilars Council Announces 2016 Board of Directors

Contact: Steve Arnoff 202.249.7113

ORLANDO (Feb. 23, 2016) - The Biosimilars Council, a division of the Generic Pharmaceutical Association (GPhA), today announced its 2016 Board of Directors. Dr. Bertrand C. Liang, Chief Executive Officer, Pfenex Inc has been re-elected as Biosimilars Council Chairman. The Council also named Bruce Leicher, Senior Vice President and General Counsel, Momenta Pharmaceuticals, Vice Chairman and Bruce Lott, Mylan’s vice president of State Government Relations and Global Biologics Policy, as Secretary/Treasurer.

“I am very pleased to continue chairing the Biosimilars Council and working to ensure a competitive legal and policy framework for biosimilars, and interchangeable biologics, in the United States,” said Dr. Liang. “As the leading manufacturer voice for these life-changing medicines, the Council plays an important role in educating payors, providers, and policy makers on the safety and efficacy of biosimilars, while encouraging a pathway that expedites patient access.”

Biologics are medicines made from living organisms, and they are used to treat diseases such as cancer, AIDS, heart disease, rheumatoid arthritis, multiple sclerosis and diabetes. Once FDA-approved, there are no clinically meaningful differences between the biosimilar and the reference (brand) biologic in terms of safety, purity and potency.

“The Biosimilars Council is a strong partner for those involved with this rapidly expanding industry. With Bert’s continued leadership, the Council will continue to be instrumental in discussions on biosimilar naming, reimbursement, state substitution and other policy and regulatory priorities that enhance patient access to more affordable medicines,” said Chip Davis, President and CEO, GPhA.

“Projected savings from biosimilars vary from $44 billion to more than $250 billion over 10 years, but that potential hinges on the creation of an environment that encourages pharmaceutical competition,” said Leicher. “The Council is right on the front lines of this effort and will continue to encourage policy that exerts downward cost pressure on our health system.”

“I’m very pleased to be a part of the Biosimilars Council representing manufacturers of more affordable therapies for patients managing many chronic and severe diseases,” said Lott. “The U.S. introduction of more biosimilars will lower treatment costs and provide patients with safe and effective choices that can translate to billions in savings for the health system.”

The Biosimilars Council Board of Directors includes representatives from the following member companies:

• Accord Healthcare
• Amneal BioSciences, LLC
• ApoBiologix
• Biocon
• Dr. Reddy’s
• Momenta Pharmaceuticals, Inc.

• Mylan Inc.
• Pfenex Inc.
• Sandoz
• Sun Pharmaceutical Industries Ltd.
• Teva Pharmaceuticals USA
• Zydus Pharmaceuticals

 

About the GPhA Biosimilars Council

The Biosimilars Council, a division of the Generic Pharmaceutical Association (GPhA), works to ensure a positive environment for patient access to biosimilar medicines. The Biosimilars Council is a leading source for information about the safety and efficacy of more affordable alternatives to costly brand biologic medicines. Areas of focus include public and health expert education, strategic partnerships, government affairs, legal affairs and regulatory policy. More information is available at www.biosimilarscouncil.org.

About GPhA

GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals fill 88 percent of the prescriptions dispensed in the U.S. but consume just 28 percent of the total drug spending. Additional information is available at gphaonline.org. Follow us on twitter: @gpha.

 

Biosimilars Council Statement Regarding the World Health Organization’s Biosimilar Naming Proposal

Contact: Steve Arnoff 202.249.7113

WASHINGTON, DC (Feb. 11, 2016)

Dr. Bert Liang, M.D., PhD, M.B.A.,CEO of Pfenex, Inc., Chair, Biosimilars Council:

"As advocates for policies that support patient access to biosimilars, the Biosimilars Council, a division of the Generic Pharmaceutical Association, is disappointed in the World Health Organization’s (WHO’s) final proposal on the Biological Qualifier (BQ), which could be a barrier to competition from these new versions of critical medicines. The system proposed by the WHO would assign a random code to the International Nonproprietary Name (INN) for biological substances. This proposal from the WHO is similar (although not exact) to the Food and Drug Administration (FDA) current guidance on the naming of biosimilars, as it is a nonsensical qualifier allowing identification of one biosimilar or biologic from another. The WHO guidelines are optional for adoption by each regulatory body, so it is expected that, rather than adopting the BQ proposed by the WHO, the FDA will continue to review the public comments received in response to its latest issued draft guidance on naming before finalization.

Further to the point of naming, there exists no compelling rationale for added identifiers for biosimilar drugs; on the contrary, based on available estimations, this will likely stifle uptake and market growth in the U.S. and other countries. The INN was designed to identify an active compound, rather than create a base for a branded naming system. Both the WHO and FDA naming proposals adding unique qualifiers to the INN of biosimilars defeats this core purpose.

In even more compelling evidence, biosimilars are used safely and effectively in Europe – as they have been for a decade – with no issues tracking these approved biosimilar drugs using the brand name. In the U.S., we have additional systems to allow the tracking of pharmaceutical drugs, including the National Drug Code (NDC) and lot number, which can be effectively used for biosimilar drugs – eliminating the need for these artificial distinctions that stand to stifle competition and may misleadingly undermine physician and patient confidence in biosimilar drugs.”

 

About the GPhA Biosimilars Council

The Biosimilars Council, a division of the Generic Pharmaceutical Association (GPhA), works to ensure a positive environment for patient access to biosimilar medicines. The Biosimilars Council is a leading source for information about the safety and efficacy of more affordable alternatives to costly brand biologic medicines. Areas of focus include public and health expert education, strategic partnerships, government affairs, legal affairs and regulatory policy. More information is available at www.biosimilarscouncil.org.

About GPhA

GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals fill 88 percent of the prescriptions dispensed in the U.S. but consume just 28 percent of the total drug spending. Additional information is available at gphaonline.org. Follow us on twitter: @gpha.

 

Statement by Christine Simmon, Senior Vice President, Policy and Strategic Alliances, Generic Pharmaceutical Association, Regarding Today’s FDA Arthritis Advisory Committee Meeting

Contact: Steve Arnoff 202.249.7113

WASHINGTON, DC (Feb. 9, 2016) - "The Generic Pharmaceutical Association (GPhA) and its Biosimilars Council commend the Food and Drug Administration (FDA) for hosting today’s Arthritis Advisory Committee Meeting on the infliximab biosimilar, an important step toward advancing science and encouraging more choices for patients who previously would have to rely on costly brand biologic medicines.

The value and impact of biosimilars will hinge on the development of smart policy that promotes access and competition. The Biosimilars Council, the leading voice for biosimilars education and advocacy efforts, is pleased to have the opportunity to inform this newer area of health policy and bring together manufacturers and other experts that continue to play an integral role in expanding patient savings and access by making these vital medicines available in the United States.

Development, production and approval of biosimilar products must be grounded in sound scientific principles. In determining that a biosimilar has ‘no clinically meaningful differences’ from its reference biologic, the Agency relies on the expertise of the same scientists that assess applications for new biological products. Approval by these experts requires the full spectrum of robust and rigorous scientific approaches as determined by FDA. For these reasons, providers, patients and others can be assured of the safety and efficacy of FDA approved biosimilars.

Moreover, a reliance on scientific standards dictates that all products with the same active ingredient should have the same International Nonproprietary Name (INN). This methodology is endorsed by numerous scientific bodies, including the U.S. Pharmacopeial Convention (USP). Alternative approaches could elevate patient safety risk, cause provider confusion and hinder the utilization of biosimilar medicines.

GPhA and Biosimilars Council members look forward to working with members of the supply chain, stakeholders and patients to move our health system closer to the day that biosimilars become widely available, enhancing access and growing health savings for millions of patients and the entire health system.”

Read the full remarks here.

 

About the GPhA Biosimilars Council

The Biosimilars Council, a division of the Generic Pharmaceutical Association (GPhA), works to ensure a positive environment for patient access to biosimilar medicines. The Biosimilars Council is a leading source for information about the safety and efficacy of more affordable alternatives to costly brand biologic medicines. Areas of focus include public and health expert education, strategic partnerships, government affairs, legal affairs and regulatory policy. More information is available at www.biosimilarscouncil.org.

About GPhA

GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals fill 88 percent of the prescriptions dispensed in the U.S. but consume just 28 percent of the total drug spending. Additional information is available at gphaonline.org. Follow us on twitter: @gpha.

 

Statement by Chip Davis, President and CEO, GPhA, Regarding Today’s Congressional Hearing on BPCIA Implementation

Contact: Steve Arnoff 202.249.7113

WASHINGTON, DC (Feb. 4, 2016) - "The House Energy and Commerce Committee today held Congress’ first oversight hearing since the enactment of the Biologics Price Competition and Innovation Act (BPCIA) in 2010.

“As the U.S. market for biosimilars takes shape, the future of these new medicines is dependent on policy decisions that promote patient access and competition,” said Chip Davis, President and CEO, Generic Pharmaceutical Association (GPhA). “Biosimilar manufacturers now have an approval pathway for safe and effective alternatives to costly brand biologic drugs. The first biosimilar has been approved under BPCIA and patients, payors and others are eager to see competition in the marketplace for biologics increase access and affordability.

The Biosimilars Council, a division of GPhA, is concerned that different international nonproprietary names for biologics and biosimilars could lead to patient and provider confusion, increasing the likelihood of prescribing errors and other unintended consequences.

The Council also urges the Centers for Medicare and Medicaid Services (CMS) to provide non-interchangeable biosimilars with a unique average sales price calculation and billing code, to ensure a competitive reimbursement. Additional clarity from currently outstanding FDA guidances on interchangeability, extrapolation and labeling are each critical to the timely availability of biosimilars in the United States. The Council urges the agency to issue these guidances promptly.

Pragmatic Congressional oversight can help ensure that the regulatory landscape supports the development of a robust marketplace for safe and effective biosimilars that enhances patient access and encourages these medicines to generate significant savings for millions of patients, payors and others who will rely on the savings they provide.”

 

About the GPhA Biosimilars Council

The Biosimilars Council, a division of the Generic Pharmaceutical Association (GPhA), works to ensure a positive environment for patient access to biosimilar medicines. The Biosimilars Council is a leading source for information about the safety and efficacy of more affordable alternatives to costly brand biologic medicines. Areas of focus include public and health expert education, strategic partnerships, government affairs, legal affairs and regulatory policy. More information is available at www.biosimilarscouncil.org.

About GPhA

GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals fill 88 percent of the prescriptions dispensed in the U.S. but consume just 28 percent of the total drug spending. Additional information is available at gphaonline.org. Follow us on twitter: @gpha.

 

Statement by Chip Davis, President and CEO, GPhA, Regarding
BsUFA Reauthorization

Contact: Steve Arnoff 202.249.7113

WASHINGTON, DC (Dec. 18, 2015) — "The Biosimilars Council, a division of the Generic Pharmaceutical Association (GPhA), is pleased that the Food and Drug Administration (FDA) is hosting a constructive dialogue on the processes and recommendations for the next Biosimilar User Fee Act (BsUFA).

As the biosimilars market in the United States is in its early stages, it is critical that policies established promote competition and create opportunities to speed patient access to safe, effective alternatives to costly brand biologic drugs.

While the FDA has set a promising foundation, fewer biosimilars are approved today than the agency projected. One important step that can be taken to expedite access to these alternatives to costly brand biologic therapies is to codify the currently outstanding biosimilars regulations. Further, FDA must have the resources it requires to provide timely detailed feedback to manufacturers during the application process.

More collaborative independent public information and education efforts can better inform patients and professionals about biosimilar safety and scientific development. That is why the Biosimilars Council efforts in 2016 will include opportunities for prescribers, providers and others to learn more about these vital medicines.

Moving forward, it is critical for FDA and industry to collaborate and focus negotiations on efforts that promote access to more affordable, high quality biosimiliars for the patients who rely on these essential medicines.”

View the Biosimilars Council presentation slides here.  

 

About the GPhA Biosimilars Council

The Biosimilars Council, a division of the Generic Pharmaceutical Association (GPhA), works to ensure a positive environment for patient access to biosimilar medicines. The Biosimilars Council is a leading source for information about the safety and efficacy of more affordable alternatives to costly brand biologic medicines. Areas of focus include public and health expert education, strategic partnerships, government affairs, legal affairs and regulatory policy. More information is available at www.biosimilarscouncil.org.

About GPhA

GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals fill 88 percent of the prescriptions dispensed in the U.S. but consume just 28 percent of the total drug spending. Additional information is available at gphaonline.org. Follow us on twitter: @gpha.

 

GPhA and Biosimilars Council Praise New Jersey Biosimilars Law

Contact: Steve Arnoff 202.249.7113

WASHINGTON, DC (November 9, 2015) — The Generic Pharmaceutical Association (GPhA) and its Biosimilars Council applaud Gov. Christie for signing New Jersey A. 2477 into law, allowing interchangeable biologic substitution at the pharmacy.

“This year for biosimilars continues to be one of progress and promise,” said Chip Davis, President and CEO, Generic Pharmaceutical Association (GPhA). “We are very pleased that state policymakers in New Jersey and across the country are ensuring pharmaceutical competition and promoting patient access to more affordable medicine.”

Twelve states plus Puerto Rico have enacted these measures in 2015.

 

About the GPhA Biosimilars Council

The Biosimilars Council, a division of the Generic Pharmaceutical Association (GPhA), works to ensure a positive environment for patient access to biosimilar medicines. The Biosimilars Council is a leading source for information about the safety and efficacy of more affordable alternatives to costly brand biologic medicines. Areas of focus include public and health expert education, strategic partnerships, government affairs, legal affairs and regulatory policy. More information is available at www.biosimilarscouncil.org.

About GPhA

GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals fill 86 percent of the prescriptions dispensed in the U.S. but consume just 27 percent of the total drug spending. Additional information is available at gphaonline.org. Follow us on twitter: @gpha.

 

Biosimilars Reimbursement Rule Could Discourage Patient Access

Contact: Steve Arnoff 202.249.7113

WASHINGTON, DC (October 30, 2015) — The Biosimilars Council, a division of the Generic Pharmaceutical Association (GPhA), is disappointed today by the Centers for Medicare & Medicaid Services’ (CMS) decision to group all biosimilars together under one payment calculation and billing code in Medicare Part B, while using a different code for the reference product.

“It is unfortunate that CMS chose to ignore the strong reservations expressed by experts from all corners of the supply chain, leading biosimilar manufacturers and others urging the agency to provide non-interchangeable biosimilars with their own independent billing codes and payment calculations. This final rule is likely to discourage investment in biosimilar therapies, making it harder for patients to access these new products in the United States,” said Chip Davis, President and CEO of GPhA.

“There is no scientific evidence that suggests it would be appropriate to blend all biosimilar products into a single payment calculation, independent of the reference product," said Bert Liang, CEO of Pfenex Inc., and Chairman of the Biosimilars Council. “While we appreciate CMS’ recognition that it would be premature to issue a rule regarding reimbursement for future interchangeable biosimilars, placing all non-interchangeable products in a single code independent of the reference product is still misguided. Non-interchangeable products are solely compared to the reference product, and not one another, making this arrangement highly unusual.”

The Biosimilars Council continues to look forward to working with CMS to develop policies that will encourage patient access to biosimilars and promote savings to the U. S health care system.

 

About the GPhA Biosimilars Council

The Biosimilars Council, a division of the Generic Pharmaceutical Association (GPhA), works to ensure a positive environment for patient access to biosimilar medicines. The Biosimilars Council is a leading source for information about the safety and efficacy of more affordable alternatives to costly brand biologic medicines. Areas of focus include public and health expert education, strategic partnerships, government affairs, legal affairs and regulatory policy. More information is available at www.biosimilarscouncil.org.

About GPhA

GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals fill 86 percent of the prescriptions dispensed in the U.S. but consume just 27 percent of the total drug spending. Additional information is available at gphaonline.org. Follow us on twitter: @gpha.

 

GPhA and Biosimilars Council Applaud California Biosimilars Law

Contact: Steve Arnoff 202.249.7113

WASHINGTON, DC (October 7, 2015) — The Generic Pharmaceutical Association (GPhA) and its Biosimilars Council applaud California for enacting a law to facilitate patient access to more affordable versions of biologic medicines.

“By enacting SB 671, Governor Jerry Brown and California legislators are demonstrating their commitment to both patient health and fiscal health in their state. This bill allows for substitution of interchangeable biologics and avoids measures that would hinder timely patient access to these products,” said Chip Davis, GPhA President and CEO.

In 2015, 11 states and Puerto Rico have passed legislation that facilitates interchangeable biologic substitution at the pharmacy. The first biosimilar was recently approved for use in the United States, and laws governing manufacturing, prescribing and dispensing are still being formed at the federal and state levels.

“With billions of dollars in health savings at stake for the nation’s patients, it is vital to make sure that the legal and regulatory framework enables competition and provides for timely access to safe, effective and more affordable therapies,” said Davis.

 

About the GPhA Biosimilars Council

The Biosimilars Council, a division of the Generic Pharmaceutical Association (GPhA), works to ensure a positive environment for patient access to biosimilar medicines. The Biosimilars Council is a leading source for information about the safety and efficacy of more affordable alternatives to costly brand biologic medicines. Areas of focus include public and health expert education, strategic partnerships, government affairs, legal affairs and regulatory policy. More information is available at www.biosimilarscouncil.org.

About GPhA

GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals fill 86 percent of the prescriptions dispensed in the U.S. but consume just 27 percent of the total drug spending. Additional information is available at gphaonline.org. Follow us on twitter: @gpha.

 

Statement by Chip Davis, President and CEO, GPhA, Regarding the Trans-Pacific Partnership Agreement

Contact: Steve Arnoff 202.249.7113

WASHINGTON, DC (October 5, 2015) — “The Generic Pharmaceutical Association (GPhA) and its Biosimilars Council strongly support efforts to improve worldwide patient access to affordable medicines. We are optimistic that the agreement announced today on the Trans-Pacific Partnership (TPP) brings us closer to achieving that goal by embracing competition from safe, effective biosimilar therapies.

Trade provisions that facilitate both the development of innovative, life-saving medicines and the availability of affordable generic medicines are a win for patients. We applaud the United States Trade Representative (USTR) and negotiating countries for working diligently in an effort to strike this balance.

GPhA and its members will continue to work with the USTR on the technical details of the final TPP to ensure that it promotes patient health and economic growth. The TPP presents an unprecedented opportunity to usher in a new era of global trade, patient access and health savings. We look forward to working with Congress and the Administration to make this historic agreement a reality.”

 

About the GPhA Biosimilars Council

The Biosimilars Council, a division of the Generic Pharmaceutical Association (GPhA), works to ensure a positive environment for patient access to biosimilar medicines. The Biosimilars Council is a leading source for information about the safety and efficacy of more affordable alternatives to costly brand biologic medicines. Areas of focus include public and health expert education, strategic partnerships, government affairs, legal affairs and regulatory policy. More information is available at www.biosimilarscouncil.org.

About GPhA

GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals fill 86 percent of the prescriptions dispensed in the U.S. but consume just 27 percent of the total drug spending. Additional information is available at gphaonline.org. Follow us on twitter: @gpha.

 

Statement by Chip Davis, President and CEO, GPhA, Regarding the Trans-Pacific Partnership Negotiations

Contact: Steve Arnoff 202.249.7113

WASHINGTON, DC (October 2, 2015) — “The Generic Pharmaceutical Association (GPhA) and its Biosimilars Council remain hopeful that discussions in Atlanta translate to Trans-Pacific Partnership (TPP) language that promotes access to treatments for patients all over the world. A TPP that encourages competition from more affordable medicines can help lower health spending.

Competition in the biologics marketplace through the creation of a pathway that ensures access to safe, effective and affordable biosimilars will reduce health costs for patients, governments and the entire healthcare system. GPhA shares the health cost concerns of the current administration and strongly agrees in principle with proposed exclusivity reductions — extending monopolies on biologic medicines is simply not sustainable.

That is why GPhA urges USTR to adhere to the letter and spirit of the May 10th agreement’s provisions regarding exclusivity for biologic medicines. Embracing the precedent set by the May 10th agreement allows the United States to remain globally competitive while establishing balanced intellectual property provisions among trading partners. It is also critical that this agreement avoids locking the United States in a policy position that limits Congress from modifying U.S. pharmaceutical law in the future.

Further, “pharmacovigilance exclusivity,” is not an appropriate justification for extending brand biologic exclusivity. Pharmacovigilance obligations are a mandate of regulatory authorities for biologics and biosimilars. Such regulatory requirements do not need to be addressed in trade negotiations, and should not be used as rationale for seeking any additional exclusivity.

GPhA welcomes the opportunity to work with USTR and others to take steps that ensure the United States is well positioned to be competitive in the burgeoning biosimilars market.”

 

About the GPhA Biosimilars Council

The Biosimilars Council, a division of the Generic Pharmaceutical Association (GPhA), works to ensure a positive environment for patient access to biosimilar medicines. The Biosimilars Council is a leading source for information about the safety and efficacy of more affordable alternatives to costly brand biologic medicines. Areas of focus include public and health expert education, strategic partnerships, government affairs, legal affairs and regulatory policy. More information is available at www.biosimilarscouncil.org.

About GPhA

GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals fill 86 percent of the prescriptions dispensed in the U.S. but consume just 27 percent of the total drug spending. Additional information is available at gphaonline.org. Follow us on twitter: @gpha.

 

Biosimilars Council Regarding Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2016 proposed rule

Biosimilars Council Regarding Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems CY 2016 Proposed Rule

Statement by Chip Davis, President and CEO, GPhA, Regarding the Launch of the First Biosimilar

Contact: Steve Arnoff 202.249.7113

WASHINGTON, DC (September 3, 2015) — "The Biosimilars Council, a division of GPhA, is very pleased that a federal appeals court has cleared the way for patients to access the first FDA-approved biosimilar. The launch of Zarxio is a victory for all champions of improving access and affordability in healthcare.

Now, regulatory agencies must ensure that policies pertaining to reimbursement, interchangeability, and other issues continue to foster the development of a robust biosimilars marketplace ensure the availability of these affordable alternatives to costly brand biologics, and delivers cost savings for patients and America’s healthcare system.

The Biosimilars Council looks forward to working with all stakeholders to ensure the creation of a positive environment for patient access to Zarxio and the wave of biosimilars awaiting approval. We are committed to our continued efforts to educate providers, prescribers, and patients about the safety and quality profiles of these new medicines."

 

About the GPhA Biosimilars Council

The Biosimilars Council, a division of the Generic Pharmaceutical Association (GPhA), works to ensure a positive environment for patient access to biosimilar medicines. The Biosimilars Council is a leading source for information about the safety and efficacy of more affordable alternatives to costly brand biologic medicines. Areas of focus include public and health expert education, strategic partnerships, government affairs, legal affairs and regulatory policy. More information is available at www.biosimilarscouncil.org.

About GPhA

GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals fill 86 percent of the prescriptions dispensed in the U.S. but consume just 27 percent of the total drug spending. Additional information is available at gphaonline.org. Follow us on twitter: @gpha.

 

Statement by Dr. Bertrand C. Liang, Chairman, Biosimilars Council, Regarding FDA Proposals on Biosimilars Naming:

Contact: Steve Arnoff 202.249.7113

WASHINGTON, DC (August 27, 2015) — "The FDA’s proposals today on naming conventions for biosimilars warrant serious scrutiny for their potential to erect barriers to patient access to new, more affordable medicines, and jeopardize their safety.

Because the Biosimilars Council shares the agency’s deep commitment to patient safety, we believe that biologics and biosimilars should be required to have the same International Nonproprietary Name (INN) with no added “FDA-designated suffix.” Adverse events and product recalls for small-molecule and biologic drugs already are successfully identified using the national drug code (NDC code), and lot number and company name, and there is no compelling evidence that biosimilars should be handled differently. There is already a precedent for shared names (e.g., erythropoietins, somatropin, interferon), which has not resulted in any known patient safety issues. Shared INNs without suffixes are also safely and effectively utilized in EU, Canada, Australia, and Japan. Adding a random collection of letters to the product’s nonproprietary name confers no additional safety benefit, and in fact would require the healthcare professional to be armed at all times with a code-breaking reference.

Moreover, the legislative intent of the biosimilars approval pathway included in the Patient Protection and Affordable Care Act was to support the development of less expensive but equally effective alternatives to biologic drugs. Yet, today’s proposals could create an unnecessary barrier to the benefits of FDA-determined interchangeability. Patients, prescribers and dispensers of these drugs need to be able to easily identify which drugs bear a relation to one another in order to maximize the potential savings from the biosimilar approval pathway.

We look forward to working with FDA and other healthcare stakeholders to ensure that names for biologics, biosimilars and interchangeable biosimilars support patient access to safe, effective and more affordable alternatives to brand-name medicines."

 

Biosimilars Council Urges CMS to Wait on Part B Reimbursement for Interchangeable Biologic Products

Regulation is Premature Without FDA Clarity on Interchangeable Biologic Pathway

Contact: Steve Arnoff 202.249.7113

WASHINGTON, DC (August 25, 2015) — The Biosimilars Council, a division of the Generic Pharmaceutical Association (GPhA), continues to raise concerns about the proposed rule issued by the Centers for Medicare and Medicaid Services (CMS) regarding biosimilars’ reimbursement under Medicare Part B.

"The Biosimilars Council believes that each non-interchangeable biosimilar should receive a unique code," said Dr. Bertrand C. Liang, Chief Executive Officer, Pfenex, Inc. and Chairman, Biosimilars Council. “However, at this time, the pathway is insufficiently developed by the Food and Drug Administration to support regulation related to coverage, coding and payment of interchangeables."

While the availability of biosimilars in the United States promises to improve patient access to these new medicines cost-effectively, the Council believes the current CMS proposal to group all biosimilars to the same payment calculation and billing code, separate from the reference product, would discourage innovation and erect barriers todeveloping new biosimilar and interchangeable biologics, decreasing access to these important agents.

“Grouping all biosimilars together under one payment calculation and billing code, while using a different code for the reference product, creates confusion, making it difficult to write coverage policies. In some instances this practice could have the unintended consequence of discouraging investment in the development of new biosimilar and interchangeable products to the detriment of patient access," said Liang.

The Council will file more detailed comments by the September 8 deadline. The Biosimilars Council looks forward to working with CMS and other stakeholders to help create a robust, competitive market for these medicines, and will continue urging CMS to revise the current proposal.

For more information click here.

 

About the GPhA Biosimilars Council

The Biosimilars Council, a division of the Generic Pharmaceutical Association (GPhA), works to ensure a positive environment for patient access to biosimilar medicines. The Biosimilars Council is a leading source for information about the safety and efficacy of more affordable alternatives to costly brand biologic medicines. Areas of focus include public and health expert education, strategic partnerships, government affairs, legal affairs and regulatory policy. More information is available at www.biosimilarscouncil.org.

 

Biosimilars Council Statement Regarding the CMS Part B Proposal:

Contact: Steve Arnoff 202.249.7113

WASHINGTON, DC (July 22, 2015) — The Biosimilars Council is greatly concerned about the recently proposed rule issued by the Centers for Medicare and Medicaid Services (CMS) regarding the reimbursement of biosimilar biologic products under Medicare Part B. The rule, as proposed, would discourage innovation in the biosimilars marketplace and greatly reduce incentives for manufacturers to invest in developing new biosimilar and interchangeable biologics for patients.

CMS has proposed grouping all biosimilars to the same originator biologic product under one biosimilar billing code and payment rate, and by doing so will calculate reimbursement rates under Part B by averaging the sales price of each class of biosimilars together. However, there is no scientific basis for this proposal, and it will likely only serve to discourage the development of a competitive market to create affordable medicines.

Biosimilars are tested and approved based on high similarity to a specific reference biologic. Different biosimilars to the same reference product may not share all of the indications or product presentations as allowed by the Biologics Price Competition and Innovation Act (BPCIA) and Food and Drug Administration (FDA) guidance. They are not compared to one another in any meaningful way, and grouping them together under one billing code would not allow for coverage policies that adequately distinguish between biosimilars, and serve to create confusion in the market.

Developing a consistent and predictable reimbursement scheme for biosimilars is crucial in ensuring the success of the emerging biosimilars market. In order to provide patients with access to a greater array of affordable treatments, the system must provide adequate incentives, while also eliminating confusion within the healthcare community.

The Biosimilars Council urges CMS to work with stakeholders in order to revise its proposal such that all biosimilars for any single reference product are not grouped together into a single J-code and payment rate. The Council stands ready to assist CMS in this effort, and looks forward to submitting further detailed comments to the agency.

 

About the GPhA Biosimilars Council

The Biosimilars Council, a division of the Generic Pharmaceutical Association (GPhA), works to ensure a positive environment for patient access to biosimilar medicines. The Biosimilars Council is a leading source for information about the safety and efficacy of these more affordable alternatives to costly brand biologic medicines. Areas of focus will include public and health expert education, strategic partnerships, government affairs, legal affairs and regulatory policy. More information is available at www.biosimilarscouncil.org.

 

Statement by Dr. Bertrand C. Liang, Chairman, Biosimilars Council, Regarding the "Patent Dance"

Contact: Steve Arnoff 202.249.7113

WASHINGTON, DC (July 21, 2015) — Statement by Dr. Bertrand C. Liang, Chairman, Biosimilars Council: "The Biosimilars Council applauds today’s Federal Circuit Court of Appeals decision that recognizes as optional the “patent dance” created under the Biologics Price Competition and Innovation Act (BPCIA), facilitating speedier patient access to affordable biosimilars.

As part of the first appellate interpretation of the framework for biosimilars in the United States, the court ruled that the BPCIA does not require a biosimilar applicant to provide a complete copy of its biosimilar application to the reference (brand) manufacturer upon filing, thus enabling the brand manufacturer to commence patent infringement proceedings sooner.

Today’s decision provides important clarity for both biosimilar and reference product manufacturers. The ruling ensures that a biosimilar manufacturer can pursue the most expeditious avenue for resolving patent disputes, so that patients, supply chain stakeholders and the entire U.S. healthcare system will benefit from timely access to more affordable alternatives to costly brand biologics.

This decision also will improve business planning and decision making around the patent litigation process for biosimilar and reference product manufacturers. The Biosimilars Council is pleased that the court chose to use this commonsense reading of the statute and looks forward with great anticipation to the launch of biosimilars in the United States."

 

The Biosimilars Council Announces Chairman of the Board of Directors, Officers

Contact: Steve Arnoff 202.249.7113

WASHINGTON, DC (July 21, 2015) — The Biosimilars Council, a division of the Generic Pharmaceutical Association (GPhA) that works to educate patients and health professionals and to ensure a positive regulatory and policy environment for patient access to biosimilar medicines, today announced the election of the first Chairman of its Board of Directors.

Dr. Bertrand C. Liang, Chief Executive Officer, Pfenex Inc., will be the inaugural Biosimilars Council Chairman. The other leadership roles are Vice Chairman John Pakulski, Executive Director and Head U.S. Biopharmaceutical Affairs, Sandoz, and Treasurer Bruce Lott, Vice President of State Government Relations and Global Biologics Policy, Mylan Inc.

“I am extremely excited to lead the Biosimilars Council efforts to collaborate with patients, health professionals, regulatory agencies and elected officials in order to ensure a positive environment for these promising medicines,” said Liang. “Biosimilars are poised to play a critical role in our nation’s health system — providing patients with safe, effective, more affordable alternatives to costly brand biologic therapies. As the Food and Drug Administration moves forward with its review of biosimilars applications, it is more important now than ever to establish an effective legal and regulatory foundation and ensure that patients and professionals are educated about these medicines. I look forward to working closely with the FDA and other agencies to create a pathway that encourages adoption of these life-impacting drugs.”

The potential savings from biosimilars is great, according to experts cited in The Next Frontier for Access to Medicines: Biosimilars and Interchangeable Biologics, an educational handbook offered by the Biosimilars Council. Estimates from various economic impact studies pin the projected savings from $44 billion on the low end to as high as $250 billion over the first 10 years that only 11 of the most likely biosimilars are available to patients.

“GPhA and its Biosimilars Council remain focused on preserving and promoting access and savings from more affordable medicines,” said Ralph G. Neas, President and CEO, GPhA. “The Biosimilars Council is an unrivaled resource for anyone seeking to navigate this emerging industry, build relationships and be directly involved in formative regulatory, reimbursement, political, and policy conversations.”

The Biosimilars Council Board of Directors includes representatives from the following member companies:

• Amneal BioSciences, LLC
• ApoBiologix
• Biocon
• Dr. Reddy’s
• Momenta Pharmaceuticals, Inc.
• Mylan Inc.
• Pfenex Inc.
• Sandoz
• Sun Pharmaceutical Industries Ltd.
• Teva Pharmaceuticals USA
• Therapeutic Proteins International
• Zydus Pharmaceuticals

 

About the GPhA Biosimilars Council

The Biosimilars Council works to ensure a positive regulatory, reimbursement, political and policy environment for patient access to biosimilar medicines, and will educate the public and patients about the safety and effectiveness of biosimilars.  Areas of focus will include education, access, the nascent regulatory environment, reimbursement and legal affairs.  Additional information is available at www.biosimilarscouncil.org.

About GPhA

GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals fill 86 percent of the prescriptions dispensed in the U.S. but consume just 27 percent of the total drug spending. Additional information is available at gphaonline.org. Follow us on twitter: @gpha.

 

Biosimilars Council Joins Pharmacies, Payers and Others in Message to FDA & HHS: Require Same Names for Biologics and Biosimilars to Ensure Patient Safety

Contact: Steve Arnoff 202.249.7113

WASHINGTON, DC (June 30, 2015) — The Biosimilars Council, a division of the Generic Pharmaceutical Association (GPhA), strongly urges the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) to avoid any departure from the currently accepted international nonproprietary naming (INN) system. In a letter sent today to HHS and FDA, the Biosimilars Council joined a diverse group of healthcare stakeholders to raise shared concerns that adopting distinguishable names for biosimilars and biologics would erect barriers to patient access to new, more affordable medicines and could jeopardize their safety.

"Organizations representing the nation's pharmacies, pharmacists, insurers, state employee retirement systems, taxpayers, and others agree that biologics and biosimilars should share the same name in order to ensure patient safety and avoid confusion among providers and dispensers," said Ralph G. Neas, President and CEO, GPhA.

The letter states:

"We share the FDA's deep commitment to patient safety, and as such, we believe that biologics and biosimilars should be required to have the same International Nonproprietary Name (INN). Requiring different INNs for biologics and biosimilars could lead to patient and prescriber confusion, increasing the possibility of medication errors, and would also effectively separate the biosimilar from existing safety information about the underlying molecule."

Further, these groups believe that the current mechanisms in place (e.g., NDC code, lot number, brand name, manufacturer, etc.) are more than sufficient to allow for the tracking of important safety information related to new biosimilar products:

"We are concerned that any unnecessary changes may interfere with current pharmacy safety alert systems used by both retail and community pharmacists. In addition, because adverse events and product recalls for small-molecule and biologic drugs already are successfully identified using the national drug code (NDC code) and lot number, there is no compelling evidence that biosimilars should be handled differently."

The letter also notes dispensing complications that could arise, resulting in "massive confusion among pharmacists, payers, and PBMs" that could "inhibit patient access to these lifesaving medicines."

"The Biosimilars Council welcomes the opportunity to work with FDA and others to ensure that the biosimilar market in the United States optimizes patient access to safe, effective and more affordable alternatives to brand-name biologics," said Neas.

The letter is available here. The full list of signatories includes:

• Academy of Managed Care Pharmacy (AMCP)
• American Pharmacists Association (APhA)
• America's Health Insurance Plans (AHIP)
• The Biosimilars Council
• California Public Employees Retirement System (CalPERS)
• Council for Citizens Against Government Waste
• CVS Health
• Express Scripts
• Healthcare Supply Chain Association (HSCA)
• National Association of Chain Drug Stores (NACDS)
• National Coalition on Health Care (NCHC)
• Ohio Public Employees Retirement System (OPERS)
• Pharmaceutical Care Management Association (PCMA)
• Premier healthcare alliance
• Prime Therapeutics
• Public Sector Health Care Roundtable
• Rite Aid
• UAW Retiree Medical Benefits Trust
• Walgreens

 

GPhA and Biosimilars Council Praise New State Laws to Allow Automatic Substitution for Interchangeable Biologics

Contact: Steve Arnoff 202.249.7113

Five States Join Roster of those Pioneering Patient Access to New Medicines

WASHINGTON, DC (May 13, 2015) – The Generic Pharmaceutical Association (GPhA) and its Biosimilars Council today applaud the enactment of legislation in five states to allow automatic substitution for Food and Drug Administration (FDA) approved interchangeable biologic products.

Bills in Colorado (SB 71), Georgia (SB 51), Tennessee (SB 984), Utah (HB 279) and Washington (SB 5935) reflect core principles embraced in language agreed upon by GPhA and a wide coalition of brand manufacturers, Express Scripts, and others.

"GPhA and the Biosimilars Council commend Colorado, Georgia, Tennessee, Utah and Washington for passing laws that create a competitive market for biosimilar products and provide patient access to affordable versions of these critical medicines," said Ralph G. Neas, President and CEO, GPhA. "We are pleased these states have embraced a framework for these new medicines that reflects our organizations’ core principles: uphold the current pharmacy practice of automatic substitution; rely on the science-based determination of interchangeability by the Food and Drug Administration (FDA); and treat interchangeables and their corresponding brand biologics the same during dispensing at the pharmacy."

As biosimilars become available in the United States, states likely will pursue legislation that governs automatic substitution of biological products that the FDA deems interchangeable.

Since 2012, state substitution legislation has evolved significantly and continues to be introduced across the country. The GPhA position has not changed: the association strongly opposes legislation that includes mandatory prescriber notification requirements which could undermine the safety and effectiveness of biosimilars. Importantly, in the laws passed in these five states, communication would occur whether an originator biologic or an interchangeable biologic is dispensed, providing a level, competitive playing field for all of these medicines.

Notification, which GPhA opposes, is an alert before the medication is dispensed that a biosimilar or interchangeable biologic will be substituted for a brand biologic. Conversely, communication, a practice favored by GPhA and the broad coalition in support of last year’s compromise, takes place once the drug is dispensed and usually occurs automatically through electronic records, giving patients and providers comfort without altering existing pharmacy practice.

"The GPhA Biosimilars Council looks forward to working with state legislatures, supply chain participants, stakeholders, patients and others to expedite access to safe and effective biosimilar medicines," said Neas.

 

GPhA Launches Biosimilars Council, New Industry Group Will Educate and Advocate for Patient Access to Safe, Affordable Lifesaving Medicines

Contact: Steve Arnoff 202.249.7113

Biosimilars Council Releases First Biosimilars Handbook for U.S. Audience As Educational Resource for Patients, Policymakers, Health Professionals

WASHINGTON, DC (April 16, 2015) – The Generic Pharmaceutical Association (GPhA) is pleased to announce today’s launch of the Biosimilars Council, a division of GPhA.

"Following unanimous Board of Directors' approval, the Biosimilars Council is the culmination of the Association's longstanding and unwavering commitment to patient access to safe, affordable and lifesaving biosimilar medicines. The GPhA Biosimilars Council is designed to meet the unique needs of healthcare companies as they navigate this emerging space," said Craig Wheeler, GPhA Board Chairman, and President and CEO of Momenta Pharmaceuticals, Inc. 

"In addition to being a voice with policymakers, this new division will be an invaluable partner for patients, providers, manufacturers, consumer groups, and stakeholders from all corners of the supply chain seeking to stay apprised of critical developments regarding biosimilars," Wheeler said. The GPhA Biosimilars Council also will be a key resource for organizations seeking relationship building opportunities, and a forum for in-depth scientific, regulatory, legislative and policy discussions." 

The Biosimilars Council will comprise manufacturers and stakeholders working to ensure a positive regulatory, reimbursement, political, and policy environment that supports patient access to these more affordable new medicines. The Biosimilars Council also is the industry's first educational resource for the general public and patient groups seeking information about the safety and effectiveness of biosimilars.

Among the first offerings of the Biosimilars Council is a new educational handbook, The Next Frontier for Improved Access to Medicines: Biosimilars and Interchangeable Biologic Products. This publication explains the benefits and science behind biosimilar medicines— safe, effective alternatives to costly biologic therapies. It explains who will benefit from access to these medicines, outlines the legal and regulatory framework, and illuminates the quality manufacturing and development process in approachable language.

The GPhA Biosimilars Council will begin operations immediately, continuing the Association's long and proven track record of education and advocacy around these medicines in the state, federal, regulatory and international arenas.  As per recently adopted changes to the GPhA bylaws, a Biosimilar Board, elected by members of the Biosimilars Council, will develop the Association's biosimilar activities and programming consistent with the longstanding mission of GPhA and the association's Board of Directors. With a roster of committed members and full start-up funding, the new division will substantially supplement GPhA's already strong regulatory, government affairs, policy, communications/education team to support anticipated activities. The GPhA Biosimilars Council will welcome all biosimilar companies dedicated to bringing more affordable biosimilar medicines to US patients as it works to continue its leadership in supporting this critical emerging industry.

"GPhA and its members historically have been the industry pioneers on biosimilars, beginning with their role as the fundamental organizing force behind the law which created the biosimilar pathway.  The Biosimilars Council is the next evolution in this leadership, and will ensure these new medicines will deliver tremendous benefits for both our health and our healthcare system," said GPhA President and CEO Ralph G. Neas. "We look forward to continuing to work with our strategic partners and all stakeholders who share our vision of the transformative potential of biosimilars and interchangeable biologics."   

Visit www.biosimilarscouncil.org  for more information or to download The Next Frontier for Improved Access to Medicines: Biosimilars and Interchangeable Biologic Products.   

 

About the GPhA Biosimilars Council

The Biosimilars Council works to ensure a positive regulatory, reimbursement, political and policy environment for patient access to biosimilar medicines, and will educate the public and patients about the safety and effectiveness of biosimilars.  Areas of focus will include education, access, the nascent regulatory environment, reimbursement and legal affairs.  Additional information is available at www.biosimilarscouncil.org.

About GPhA

GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals fill 86 percent of the prescriptions dispensed in the U.S. but consume just 27 percent of the total drug spending. Additional information is available at gphaonline.org. Follow us on twitter: @gpha.