Press Statement: Biosimilars Council Commends FDA on Insulin Hearing

Monday May 13, 2019

The Biosimilars Council commends FDA for today’s hearing on the future of insulin biosimilars. Insulin has been available to America’s diabetes patients for decades and millions of patients rely on this important medicine to maintain their health and quality of life. We encourage the FDA to to build on its significant experience with insulin and foster efficient development of biosimilar insulins to lower costs and increase access for America’s diabetes patients. We applaud the agency for their attention to increasing access to insulin biosimilars for patients and urge FDA to continue educating providers and patients that transition from a reference product to a non interchangeable biosimilar will not result in changes to treatment safety or effectiveness.

The Biosimilars Council and the Association for Accessible Medicines are committed to increasing access to insulin biosimilars for patients. For more information on the promise of insulin biosimilars and recommendations on how stakeholders including FDA and industry can work together to increase patient access to these important medicines, please view our recent whitepaper.

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

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October 21–23, 2024 | Rockville, MD

GRx+Biosims™ 2024 is the leading regulatory science and policy event for the U.S. generics and biosimilars industry. Access the most recent information straight from experts at the Food and Drug Administration, grasp the latest policies shaping the industry, and acquire valuable insights to propel your professional development.