Policy Recommendations to Develop a Robust Biosimilars Market in the U.S.

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)

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Association for Accessible Medicines

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