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FDA has announced a public meeting and request for comment on proposed recommendations for the next reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years 2028 through 2032. BsUFA allows FDA to collect user fees to support the review of biosimilar biological products. The current authority expires in September 2027, and new legislation will be needed for FDA to continue collecting these fees.
BsUFA was first enacted in 2012 and has been renewed twice since then. The program is designed to give FDA additional resources—such as staffing—to help ensure efficient and predictable biosimilar application reviews. Under each reauthorization, FDA and industry agree to specific performance goals and procedures, including timelines for reviewing applications and commitments related to meetings, communication practices, and regulatory science efforts. The current BsUFA (BsUFA III) includes enhancements such as new supplement categories, review timelines, expanded support for interchangeable biosimilars, improved inspection communication, and investments in IT and data modernization.
As part of the reauthorization process for BsUFA IV, FDA is seeking public input before it begins negotiations with industry. FDA is specifically interested in feedback on the performance of the current BsUFA program, which elements should be kept, changed or discontinued, whether any new components should be added, and whether the current fee structure should be updated to better support biosimilar development and timely patient access.
The public meeting will be held on December 3, 2025, from 9 a.m. to 12 p.m. EST, both in person at FDA's White Oak Campus and virtually. After the meeting, FDA will continue to accept written comments until January 2, 2026. A transcript of the meeting and all submitted comments will be posted online once available.
Stay tuned for further updates.
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