FDA Seeks Input on Biosimilar Fee Hike for 2028
Published Date: 11/24/2025
Notice
Summary
The FDA is gearing up to renew the Biosimilar User Fee Act, which helps fund the review of biosimilar drugs from 2028 to 2032. They’re hosting a public meeting on December 3, 2025, and want your thoughts by January 2, 2026. This affects drug makers and patients by keeping biosimilar reviews speedy and efficient, with fees supporting the process.
Analyzed Economic Effects
3 provisions identified: 2 benefits, 1 costs, 0 mixed.
Keeps Biosimilar Reviews Funded
The FDA is seeking reauthorization of the Biosimilar User Fee Act for fiscal years 2028 through 2032. The law lets FDA collect user fees so it can hire staff and improve systems to keep biosimilar reviews moving and make biosimilar therapies available to patients sooner; the current authority expires in September 2027.
Drug Makers Will Pay User Fees
If reauthorized for FYs 2028 through 2032, BsUFA authorizes FDA to assess and collect fees from drug companies that submit marketing applications for biosimilar biological products. The notice notes the current legislative authority expires in September 2027 and invites input on fee structures and amounts by January 2, 2026.
Expedited Reviews and Interchangeability Work
The current BsUFA (BsUFA III) includes new supplement categories, timelines, and performance goals to expedite review of supplemental biosimilar applications and establishes a regulatory science pilot to advance development of interchangeable biosimilars. Those procedures aim to improve the efficiency of development and review for biosimilar and interchangeable products.
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