FDA plans meeting to renew biosimilar drug review fees
Published Date: 9/25/2026
Notice
Summary
The FDA is gearing up to renew the Biosimilar User Fee Act, which helps fund the review of biosimilar drug applications. This affects drug makers and the public by ensuring faster, smoother approval processes from 2028 to 2032. They’re hosting a public meeting on October 26, 2026, and want your comments by November 25, 2026, to shape the future of this important program.
Analyzed Economic Effects
8 provisions identified: 4 benefits, 3 costs, 1 mixed.
BsUFA Reauthorization Enables User Fees
The FDA proposes reauthorizing the Biosimilar User Fee Act (BsUFA) to cover fiscal years 2028 through 2032, which would allow FDA to collect user fees to support biosimilar application reviews. The notice warns that the current authority expires in September 2027 without new legislation.
New Tiered Application Fee and Fee Cuts
BsUFA IV would change fee rules: it would eliminate initial, annual, and reactivation Biosimilar Product Development (BPD) fees and introduce a tiered application fee where the same sponsor filing substantially similar BLAs the same day pays no additional fee and pays half fee if filed on a prior day. The proposal also removes statutory fee differentiation based on clinical data for the full application fee.
Small Business Waiver Limited to U.S. Companies
BsUFA IV proposes to limit eligibility for the small business fee waiver to companies based in the United States (applicants created or organized under State law).
Faster, Clearer Review Timelines and Communication
FDA proposes several process changes to shorten and clarify reviews, including replacing supplement categories with 4- or 6-month review timelines, a provisional determination process for applications blocked by exclusivity, allowing FDA to work up to 60 days past an application goal date to resolve late issues, and a new target action date notification process. These changes are aimed at reducing delays in biosimilar approvals.
New CMC Facility Lifecycle Program and Meetings
BsUFA IV proposes a risk-based lifecycle program for chemistry, manufacturing, and controls (CMC) facility assessments that includes a new single CMC facility pre-submission meeting, optional post-pre-license inspection (PLI) meetings, and post-action meetings for facility-driven complete responses. FDA would also conduct a third-party assessment and a public workshop to evaluate the program.
Greater Financial Transparency and Staffing Protections
BsUFA IV would continue and expand financial transparency measures: FDA will publish a 5-year financial plan with annual updates, update topics in the annual Financial Report to Congress, offer annual technical staff meetings with industry, and propose a personnel compensation and benefits (PC&B) set-aside to preserve funding needed to restaff BsUFA to FY2025 levels. The Capacity Planning Adjustment would be unavailable until BsUFA-funded PC&B spend exceeds the PC&B target amount.
180-Day Timeline for BLA Transfer Revocation/Reissuance
To facilitate transfers of 351(k) biologics license applications (BLAs) between applicants, FDA proposes a 180-day timeline for revoking and reissuing licenses after a complete transfer request, with exceptions for BLAs regulated by multiple FDA centers or BLAs with outstanding facility issues.
Sunsetting Regulatory Science Pilot Program
FDA proposes to sunset the BsUFA regulatory science pilot program at the end of BsUFA III because its goals were met. If FDA uses BsUFA funds for regulatory science research in BsUFA IV, the Agency would notify industry and make results public as appropriate.
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