Ten Years of Biosimilars in the U.S.

Monday October 26, 2020

The Biologics Price Competition and Innovation Act of 2010 (BPCIA) provides a framework for biosimilars approval, adoption and access in the U.S. Since BPCIA was passed 10 years ago, 28 biosimilars have been approved, providing patients with lower-cost, life-changing medicines that treat cancer, rheumatoid arthritis, Crohn’s and more. But not all biosimilars are accessible to patients.

FDA-approved biosimilars are just as safe and effective as brand biologics. As the United States looks for ways to lower drug costs, increasing access and use of biosimilars will provide millions of U.S. patients with the cost-saving benefits from this growing category of drugs.

Biosimilars adoption in the U.S. health care system is within reach. However, the continued success of biosimilars for the next 10 years and beyond is dependent on the decisions made by all stakeholders today. While approvals have increased, access and use have not. The events of 2020 have made it clear that health care solutions are needed that improve patient access to medicines and increase savings for the entire U.S. health care system. Biosimilars are an essential part of this reform. Fulfillment of the biosimilar promise can happen if we educate the medical profession as well as federal and state policymakers.

Join our reflections on these last 10 years and discuss how to make the next 10 years even better by using our Instagram filter and including #b10similars on your social media posts to engage physicians, patients and policymakers in the journey and potential of biosimilars. Find a whole timeline of the history of biosimilars, as well as important resources on our BPCIA website.

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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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:



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.