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We believe that patients should have access to innovative medicines.

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Our mission is to conduct effective advocacy for public policies that encourage the discovery of important, new medicines for patients by biopharmaceutical research companies.

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About PhRMA

The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading innovative biopharmaceutical research companies, which are laser focused on developing innovative medicines that transform lives and create a healthier world. Together, we are fighting for solutions to ensure patients can access and afford medicines that prevent, treat and cure disease. Over the last decade, PhRMA member companies have invested more than $850 billion in the search for new treatments and cures, and they support nearly five million jobs in the United States.

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For information on how innovative medicines save lives, please visit:  
www.PhRMA.org
www.VotersforCures.org
www.AmericasMedicines.com
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www.X.com/PhRMA 

The Biosimilars User Fee Act (BsUFA) provides the FDA supplemental resources and staffing to support greater consistency and predictability in the regulatory review of biosimilar and interchangeable biosimilar products. Since enactment in 2012, BsUFA has played an essential role in strengthening the FDA’s ability to implement a regulatory approach for biosimilars that is consistent with the agency’s gold standard science-based review.

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Fact Sheet

FDA

Biologics and Biosimilars

The Importance of the Biosimilar User Fee Act in Bringing New Options to Patients and Increasing Competition

December 16, 2025

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