The Biosimilar User Fee Act funds FDA review of biosimilar applications, and the current authorization expires in September 2027. This hybrid public meeting — , 9 a.m. to 12 p.m. ET — is where the FDA presents its proposed recommendations for the FY 2028–2032 program and the public gets its statutory chance to respond.

Dates, venue and comments

  • Meeting: 26 October 2026, 9 a.m.–12 p.m. ET
  • Venue: FDA White Oak Campus, 10903 New Hampshire Ave., Building Conference Center, White Oak Great Room, Silver Spring, MD
  • Virtual: Microsoft Teams; see the FDA event page for connection details
  • Comment deadline: written or electronic comments on the proposed recommendations due 25 November 2026
  • Docket: FDA-2015-N-3326
  • Organizer: US Food and Drug Administration

Why this meeting matters

BsUFA sets what biosimilar sponsors pay the FDA and what review-performance goals the agency commits to in return. The statute directs FDA to publish its reauthorization recommendations, hold this meeting for public comment, and take written comments afterward — so the record built here shapes the user-fee agreement biosimilar developers will operate under from FY 2028 through 2032.

Who should attend

Regulatory affairs, government affairs and market-access leaders at biosimilar and reference-product sponsors tracking FDA review-performance commitments, plus policy staff at trade associations preparing formal comments. Tracking the device side of FDA user-fee reauthorization instead? MDUFA VI's public meeting covers the parallel device user-fee process, and the full events directory lists everything we have verified.

Frequently asked questions

Is the BsUFA reauthorization public meeting free to attend?

The FDA's event page and Federal Register notice do not list a registration fee for either format. Exact registration mechanics were not surfaced in the sources reviewed for this listing — confirm directly with the FDA event page before making plans.

Can I attend the BsUFA meeting virtually?

Yes. The meeting is hybrid: in the White Oak Great Room and virtually via Microsoft Teams.

What is BsUFA and why does this meeting matter?

The Biosimilar User Fee Act authorizes the FDA to collect user fees to fund review of biosimilar biological product applications. Current authority expires in September 2027, and this meeting presents the FDA's proposed recommendations for the FY 2028–2032 reauthorization for public comment, with written comments accepted through 25 November 2026.

Sources & further reading

  1. FDA. Public Meeting on the Reauthorization of the Biosimilar User Fee Act (BsUFA) — 10/26/2026. fda.gov
  2. Federal Register. Reauthorization of the Biosimilar User Fee Act; Public Meeting; Request for Comments, Docket No. FDA-2015-N-3326. federalregister.gov

Event details are published by the organizer and can change. Confirm dates, format and registration with the FDA before making plans. Verified via WebSearch corroboration (direct organizer-page fetch was blocked this session) — last checked 25 September 2026.