Biosimilars Council Statement Applauding CMS Proposal to Encourage More Rapid Biosimilar Adoption in Medicare

Thursday November 9, 2023

The Association for Accessible Medicines and its Biosimilars Council applaud CMS’s November 6 proposal to allow Medicare Part D plans to treat formulary substitutions of certain biosimilar biologic products as “maintenance changes.” Currently, Part D plans must obtain prior approval from CMS to update their formulary with a lower-cost biosimilar instead of the brand biologic. The new CMS proposal would give plans the flexibility needed to encourage more rapid adoption of biosimilars. As a result, patients will benefit from earlier access to equally effective but lower-cost biosimilar treatment options.

Biosimilars are a key tool in the fight against the skyrocketing costs of prescription drugs and broadening patient access to the highest priced category of medicines. Indeed, since their launch in 2015, they have delivered patients, taxpayers and the healthcare system nearly $24 billion in savings. This proposal would have an immediate impact on reducing expenses for beneficiaries and the Medicare program, granting Medicare beneficiaries widespread access to these lower-cost biosimilar options. We look forward to working with the agency to ensure finalization of this proposal.

For media inquiries, contact the Communications department at [email protected].

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 less than 18 percent of total drug spending.

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