Biosimilars Council Comments on FDA Draft Guidance on Labeling for Biosimilar and Interchangeable Biosimilar Products

Monday November 27, 2023

The Biosimilars Council applauds the FDA’s draft Labeling for Biosimilar and Interchangeable Biosimilar Products guidance. The guidance incorporates FDA’s expertise in clarifying that, as a scientific matter, there is no difference between biosimilars and interchangeable biological products. Biosimilars have been used in the U.S. for more than 700 million days of patient therapy. Read the Council’s full submitted comments here.

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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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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:

 

 

Register Now! February 5–7, 2024 | Tampa, Florida

AAM’s annual meeting Access! 2024 brings together policymakers, influential speakers and industry leaders to chart the future of generics and biosimilars. Discussions center around the business, breakthroughs and politics that shape our industry. It’s the opportunity to hear firsthand from world-renowned speakers and learn about where our industry is heading and what our future holds.