PhRMA Statement on the Biosimilar User Fee Act (BsUFA) IV Performance Goals Letter

WASHINGTON, D.C. (September 24, 2026) - Pharmaceutical Research and Manufacturers of America (PhRMA) President and CEO Stephen J. Ubl issued the following statement today on the release of the Biosimilar User Fee Act (BsUFA) IV Performance Goals Letter:

"Biosimilars are an important part of a competitive U.S. medicines marketplace, helping lower health care costs and expanding treatment options for patients. BsUFA has played a critical role in supporting an efficient, predictable and science-based FDA review process for biosimilars since the program was established in 2012.

"BsUFA IV builds on that progress, focusing on enhancing the FDA's core review functions through improving review efficiency and ensuring the FDA's resources are used effectively to support timely review of safe and effective biosimilars. The agreement also enhances opportunities for communication between the FDA and biosimilar sponsors throughout the review process and increases transparency. Together, these improvements will help ensure a predictable and effective regulatory pathway supporting continued biosimilar development and timely access for patients.

"We encourage Congress to move swiftly to reauthorize BsUFA. The program is integral to strengthening America's biosimilar marketplace, supporting continued competition, and ultimately helping patients access the medicines they need."

About PhRMA

The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country's leading innovative biopharmaceutical research companies, which are 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. PhRMA member companies have invested more than $900 billion in the search for new treatments and cures over the last decade, supporting nearly five million jobs in the United States.

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