Developing a Robust Biosimilars Market in the U.S.

Thursday May 10, 2018

Biosimilars have the potential to improve quality of life for patients. If the right policies are put in place to cultivate a robust market, an additional 1.2 million patients will have access to biologic medicines, while also saving an estimated $54 billion over the next 10 years.

Congress must continue working with CMS and the FDA to ensure biosimilars can compete in the U.S. market. In addition to engaging with federal agencies, Congress should act on the following legislation that could impact patient access to biosimilars:

  • Increase patient access to biosimilars by co-sponsoring the CREATES Act (S. 974/H.R. 2212)
  • Protect the ability of the patent office to review drug patents by co-sponsoring the PACED Act (S. 2514)


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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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.