FDA Invites Patients to Biosimilar Fee Renewal Chats
Published Date: 12/12/2025
Notice
Summary
The FDA is inviting patients, consumer groups, and other stakeholders to join monthly meetings starting April 2026 to help shape the next Biosimilar User Fee Act, which expires in September 2027. These talks will guide how fees for biosimilar drug makers are collected in the future, ensuring everyone’s voice is heard. If you want in, let the FDA know by January 30, 2026!
Analyzed Economic Effects
2 provisions identified: 1 benefits, 0 costs, 1 mixed.
BsUFA Authorization Expires September 2027
The current Biosimilar User Fee Act authorization (BsUFA III) expires in September 2027. The notice states that BsUFA authorizes FDA to collect user fees from the regulated industry to support review of biosimilar biological products and that without new legislation FDA will no longer be able to collect those user fees for future fiscal years.
Patient & Consumer Groups: Join Monthly BsUFA Talks
If you represent a patient or consumer advocacy group, notify the FDA by January 30, 2026 to join monthly stakeholder meetings on reauthorizing the Biosimilar User Fee Act. Meetings are expected to start in April 2026, will be held monthly in person at the FDA White Oak Campus (Silver Spring, MD) and virtually via Microsoft Teams, and in-person participants must be REAL ID compliant.
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