Biosimilars Council Statement on FDA Approval of First Interchangeable Biosimilar

Thursday July 29, 2021

WASHINGTON (July 29, 2021) – AAM’s Biosimilars Council applauds the FDA’s decision to award an interchangeable designation to an insulin glargine treatment. This designation allows pharmacists to substitute interchangeable biosimilars for their prescribed reference products without the intervention of the prescriber. The agency’s action will give pharmacies greater ability to dispense safe and effective treatments at a significantly lower cost to patients, improving patient access to treatments. We look forward to working with the FDA and other policymakers to bring more biosimilars to market, boost their uptake and continue to deliver real savings for America’s patients and the health care system through competition.

Rachel Schwartz

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 20 percent of total drug spending.

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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.