The FY 2026 Biosimilar User Fees (BsUFA) have been announced! The Federal Register (FR) Notice can be found here. See the Lachman blog for additional posts regarding user fees: GDUFA, PDUFA, MDUFA, and ADUFA.
BsUFA fees are established under BsUFA III, effective for FY 2023 to FY 2027. As in FY 2024 to FY 2025, the Biological Product Development (BPD) fees did not change, which is a welcome relief and something we don’t experience often! Additionally, application and program fees decreased by 18.4% across the board! This will be a big help for applicants in this space.
BPD fees are due when the sponsor submits an IND that the FDA determines is intended to support a biosimilar biological product application or within seven calendar days after the FDA grants the first BPD meeting for a product (whichever occurs first). Application fees are due upon submission of the application. In August 2025, the FDA will issue invoices for FY 2026 annual BPD and program fees; these must be paid by October 1, 2025; however, if the BPD program is joined after the invoices are issued in August, the invoices will be issued in December.
As our readers are aware, user fees are assessed based on the projected workload. In the FR Notice, Table 4, the FDA shared the projected BsUFA III forecasted workload for FY 2026 compared to actual workloads from FY 2024, as shown below.
1Includes Supplements with Clinical Data and Labeling Supplements.
2Represents activities related to the review of materials submitted to the application file after approval.
3Represents the number of active REMS programs proportional to Center and User Fee by total number of qualifying products with the exclusion of the Opioid Shared System.
