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Taking Steps to Increase Patient Access to Life Altering Biosimilar Medicines

Thursday November 15, 2018

The burden of high prescription medicine costs for America’s patients continues to drive much of the national health care conversation and biosimilars are a key part of the solution.  There have been more FDA biosimilars approvals, increased provider interest, and growing payor efforts to drive utilization and acceptance of these more affordable versions of expensive biologics.

Specifically, UnitedHealthcare, the nation’s largest insurer, recently announced that it would begin preferring biosimilar medicines over certain expensive brand biologics for their Medicare Advantage (MA) plans. Other major insurers, Aetna and Kaiser Permanente, have publicly stated that they are actively evaluating making similar changes.

Centers for Medicare and Medicaid Services (CMS) Administrator Seema Verma is leading the charge. CMS has placed a high priority on encouraging the uptake and utilization of biosimilar medicines within the Medicare and Medicaid Programs. In August, CMS issued guidance that allows MA plans to “apply step therapy protocols…that [do] not create an undue access barrier for beneficiaries” in Medicare Part B. Under this guidance, UnitedHealthcare announced it would begin applying step therapy to certain high-cost Part B brand biologics, and begin preferring available lower-cost clinically equivalent biosimilars in those cases, for 2019.

FDA-approved biosimilars are safe, effective and less-costly alternatives to brand biologic medicines. Biosimilars have been proven to be highly similar to, and have no clinically meaningful differences from, previously approved brand biologics (known as “reference products”). Biosimilars, much like generic drugs, represent a significant opportunity to create competition in the market and expand patient access to critical medicines.

On average, currently marketed biosimilars list prices are roughly 40% lower than their brand counterparts, making biosimilars an integral component of the Administration’s stated goal of lowering drug costs for America’s patients. This is why a report last year concluded that increased biosimilars utilization would mean access to treatment for 1.2 million new patients.

We look forward to continuing to work with CMS on policies that will increase patient access to more affordable alternatives to brand biologic medicines.

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.

About AAM

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.

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The Council is involved in a number of events that focus on advancing biosimilars in the United States. Click on one below to learn more

GRx+Biosims 2019

Join us in Bethesda, Maryland on November 4-6, 2019 for the premier scientific and regulatory event for the U.S. generics and biosimilars industries.

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