Biosimilars Council Applauds the President’s Budget Proposal to Eliminate the Arbitrary Distinction between Interchangeable Biologics and Biosimilars

Wednesday March 13, 2024

Proposal would reduce confusion and increase patient access to lower cost biosimilars

WASHINGTON — The Biosimilars Council, a division of the Association for Accessible Medicines, today commented on the President’s budget proposal which includes language recommending the removal of the distinction between biosimilars and interchangeable biologics.

“The Biosimilars Council applauds the administration for including biosimilars in their proposed budget,” said Craig Burton, Executive Director, Biosimilars Council and AAM Senior Vice President, Policy and Strategic Alliances. “The distinction between interchangeable biologics and biosimilars is not supported by science and continues to permit brand misinformation. The proposal would reduce confusion and increase patient access to lower cost biosimilars. The Biosimilars Council looks forward to working with the administration and Congress to expand patient access to lower cost biosimilars.”

Currently, biosimilar medicines, which have no meaningful clinical difference from the reference product, must be designated as interchangeable before they can be distributed by pharmacists in the same fashion they can now with generic medicines. The United States is the only country in the world with this unnecessary designation for already-approved biosimilars.

President Biden’s proposed 2025 budget includes a proposal to remove this distinction and deem currently approved biosimilars to be interchangeable. In October, Sarah Yim, director of the FDA Office of Therapeutic Biologics and Biosimilars, said that there are no clinically meaningful differences between reference products and biosimilars and that the interchangeability designation does not indicate a higher level of similarity.

Biosimilars have been used in over 664 million days of patient therapy in the U.S. and have expanded patient access to care by more than 344 million days of therapy.

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About the Biosimilars Council

The Biosimilars Council, a division of the Association for Accessible Medicines, 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.