FDA Opens BsUFA Comments Ahead Of October 2026 Meeting

Fee structures governing biosimilar development through fiscal years 2028–2032 are now open for stakeholder input, with FDA scheduling a hybrid public meeting on October 26, 2026 to discuss proposed recommendations for the reauthorization of the Biosimilar User Fee Act (BsUFA). For regulatory affairs leads and biosimilar program heads, the window to shape the next five-year fee framework is narrow.

The meeting runs from 9:00 a.m. to 12:00 p.m. ET and is structured as a hybrid event, allowing both in-person and remote participation. FDA has assigned docket FDA-2015-N-3326 via the Federal Register notice issued September 24, 2026, which carries the full background documentation and submission instructions. Stakeholders unable to present at the meeting may still submit written comments through the public docket on Regulations.gov.

The public docket closes November 25, 2026, giving manufacturers, sponsors, and contract development organizations approximately nine weeks from the Federal Register notice date to formalize their positions. BsUFA reauthorization cycles directly influence review timelines, program staffing at the agency, and the fee obligations biosimilar applicants carry from IND through approval, variables that feed directly into manufacturing investment planning and capacity decisions.

Meeting agenda materials and supporting documents will be posted to the FDA event page as they become available; regulatory teams should monitor that page ahead of October 26 to ensure comment submissions are aligned with the agency's framing of the proposed recommendations.

The November 25 docket deadline represents the last formal opportunity for industry to place manufacturing-cost and approval-timeline concerns on the record before FDA advances its BsUFA reauthorization proposal toward Congress.

Source: FDA / What's New, Vaccines, Blood & Biologics RSS Feed, September 24, 2026. Federal Register docket FDA-2015-N-3326 issued September 24, 2026.