Event Recap: The Next Drugs: The Future for Biosimilars
On June 7th, The Atlantic presented “The Next Drugs: The Future for Biosimilars – An Atlantic Policy Update on Biosimilars” at the Newseum in Washington, D.C. The third in a series of Atlantic biosimilars briefings underwritten by The Biosimilars Council, the event gathered more than 100 influencers from a diverse group of stakeholders to discuss the future of biosimilars, including patient access, the patent landscape, and the role of Congress and legislation.
Drug prices remain top of mind for Americans and discussion at the event made it clear that policymakers are thinking about ways to address the issue.
U.S. Representative Peter Welch (D-VT) spoke with Steve Clemons, Washington Editor at Large, The Atlantic, about the role generics have played in the drug market. “Generic manufacturers do tremendous good in helping bring prices down,” said Rep.Welch. “The biosimilars industry has an opportunity to bring these new medications to people and provide competition.” Rep. Welch is currently sponsoring the FAST Generics Act (H.R. 2051), which would end REMS abuse and give biosimilars a clearer pathway for market entry.
The Biosimilars Council is committed to safeguarding patient safety. Our members strongly support current FDA-mandated REMS programs to ensure that the beneﬁts of a drug outweigh its safety risks. You can learn more at www.stopREMSabuse.com.
There was also robust conversation about the patent litigation landscape for biosimilars, specifically on the Sandoz Inc. v. Amgen Inc. case and the impact of the Supreme Court’s ruling on the biosimilar patent dance and market exclusivity. The discussion was timely – the Court issued its ruling the following week, unanimouslyoverturning a lower court decision that had effectively extended the brand manufacturer’s opportunity for monopoly protection for an additional six months. The ruling is a huge victory for patients and consumers and will support faster access to lower-cost biosimilar medicines for millions of patients facing life-threatening diseases, like cancer and multiple sclerosis.
“We need to separate both patents that protect new cures from those that are designed to delay patient access to biosimilars. There are certain patents out there for certain molecules that I think we would all agree don’t protect new cures but are rather designed to delay patient access through abuse of litigation and various other strategies.”
– Phil Nickson, Associate General Counsel, Intellectual Property, Momenta Pharmaceuticals
The Council was honored to champion this forum as part of our ongoing campaign to educate and engage patients, providers and policymakers about the opportunities and challenges facing the future of biosimilars and the healthcare industry. We look forward to continuing the dialogue on these issues in September at our annual conference, Leading on Biosimilars. Reserve your spot here: http://biosimilarscouncil.org/leading-on-biosimilars
Our special thanks to all who participated, especially:
- Representative Peter Welch (D-VT)
- Steve Clemons, Washington Editor at Large, The Atlantic
- Bruce Artim, Senior Director, Federal Government Affairs, Eli Lilly and Company
- Courtenay Brinckerhoff, Partner, Foley & Lardner LLP
- Phil Nickson, Associate General Counsel, Intellectual Property, Momenta Pharmaceuticals
- Olga Khazan, Staff Writer, The Atlantic
- Emily Akhtarzandi, Managing Director, AtlanticLIVE
If you were unable to join the live event, the full video is available here:
You can review Tweets from participants at http://bit.ly/2mTNWTH.
About the Biosimilars Council
The Biosimilars Council, a division of the Association for Accessible Medicines (AAM), 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 on our about page.
AAM is driven by the belief that access to safe, quality, effective medicine has a tremendous impact on a person’s life and the world around them. Generic and biosimilar medicines improve people’s lives, improving society and the economy in turn. AAM represents the manufacturers and distributors of finished generic pharmaceuticals and biosimilars, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals are 90 percent of prescriptions dispensed in the U.S. but only 23 percent of total drug spending. Additional information is available at www.accesiblemeds.org.