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FDA holds public meeting on proposed BsUFA reauthorisation for fiscal years 2028 to 2032

🇺🇸 FDA CBER · Tue 27 Oct 2026

FDA has posted the agenda and slides from its 26 October meeting on proposed recommendations for renewing the Biosimilar User Fee Act, with a docket open for comments.

The US Food and Drug Administration held a public meeting on 26 October 2026 to discuss proposed recommendations for reauthorising the Biosimilar User Fee Act (BsUFA) for fiscal years 2028 to 2032. The session ran from 9:00 a.m. to 12:00 p.m. ET at the White Oak campus in Silver Spring, Maryland, with a virtual option.

The agency's Center for Biologics Evaluation and Research hosts a webpage for the event, which carries the agenda and the slides presented, both as PDF files. The page does not summarise what was said at the meeting or detail the proposed recommendations themselves.

Background and instructions for submitting comments are set out in a Federal Register notice issued on Friday 25 September under docket FDA-2015-N-3326. The event page says the public docket closes on 25 November 2025. That year appears inconsistent with a meeting held in 2026, so stakeholders should confirm the actual closing date in the docket itself.

As general context, BsUFA authorises FDA to collect fees from biosimilar sponsors to support the review of biosimilar applications. The programme is renewed periodically, and the process includes public input on the terms of the next cycle.

What it means for your team

  • Biosimilar developers and market-access teams should review the posted agenda and slides to see which proposed recommendations will shape fees and review commitments for FY2028 to FY2032.
  • Regulatory affairs teams should check docket FDA-2015-N-3326 directly to confirm the comment deadline, given the date discrepancy on the event page.
  • Trade associations and sponsors planning to comment should align internal positions with the docket timetable, as the page gives no detail on next steps.

Official source: FDA CBER ↗

Article written by VigiEye from the official source (FDA CBER). AI-assisted; check the source before acting.

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