# 2026-19660: FDA plans meeting to renew biosimilar drug review fees 2026-19660, Reauthorization of the Biosimilar User Fee Act; Public Meeting; Request for Comments, is a Federal Register notice from Health and Human Services Department, Food and Drug Administration published 2026-09-25, effective The public meeting will be held on October 26, 2026, from 9 a.m. to 12 p.m. Eastern Time, and will take place in person and virtually. Either electronic or written comments on the proposed recommendations must be submitted by November 25, 2026.; PRIA reads it as touching household money (as of 2026-10-02). - Canonical: https://policyrisk.com/federal-register/2026-19660 - As of: 2026-10-02 - Plain-text twin of the page above; the HTML and this file carry the same facts. ## Facts - Document number: 2026-19660 - Title: Reauthorization of the Biosimilar User Fee Act; Public Meeting; Request for Comments - Type: Notice - Agencies: Health and Human Services Department; Food and Drug Administration - Citation: 91 FR 60962 - Published: 2026-09-25 - Effective: The public meeting will be held on October 26, 2026, from 9 a.m. to 12 p.m. Eastern Time, and will take place in person and virtually. Either electronic or written comments on the proposed recommendations must be submitted by November 25, 2026. - Comments close: 2026-11-25 - Significant: no - Touches household money: yes - Regulation identifier numbers: none - Last updated: 2026-10-02 ## In one line FDA plans meeting to renew biosimilar drug review fees ## 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. ## Abstract The Food and Drug Administration (FDA, the Agency, or we) is hosting a hybrid public meeting to discuss proposed recommendations for the reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years (FYs) 2028 through 2032. The BsUFA authorizes FDA to collect user fees to support the process for the review of biosimilar biological product applications. The current legislative authority for BsUFA expires in September 2027. At that time, new legislation will be required for FDA to continue collecting user fees in future fiscal years. Following discussions with the regulated industry and periodic consultations with public stakeholders, the Federal Food, Drug, and Cosmetic Act (the FD&C Act) directs FDA to publish the recommendations for the reauthorized program in the Federal Register, hold a meeting at which the public may present its views on such recommendations, and provide for a period of 30 days for the public to provide written comments on such recommendations. FDA will then consider such public views and comments and revise such recommendations, as necessary. ## Effects PRIA read - BsUFA Reauthorization Enables User Fees: cost, medium. 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: mixed, medium. 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 d… - Small Business Waiver Limited to U.S. Companies: cost, medium. 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: benefit, medium. 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 resolv… - New CMC Facility Lifecycle Program and Meetings: benefit, medium. 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… - 180-Day Timeline for BLA Transfer Revocation/Reissuance: benefit, low. 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: cost, low. 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. - Greater Financial Transparency and Staffing Protections: benefit, medium. 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) s… ## Related documents - [2026-16296](https://policyrisk.com/federal-register/2026-16296): Substances Generally Recognized as Safe, 2026-08-11 - [2026-14073](https://policyrisk.com/federal-register/2026-14073): Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign E…, 2026-07-13 - [2026-13047](https://policyrisk.com/federal-register/2026-13047): Establishment Registration and Product Listing for Tobacco Products, 2026-06-29 - [2025-04978](https://policyrisk.com/federal-register/2025-04978): Nonprescription Drug Product With an Additional Condition for Nonprescription Use, 2025-03-25 - [2025-01840](https://policyrisk.com/federal-register/2025-01840): Nonprescription Drug Product With an Additional Condition for Nonprescription Use, 2025-01-27 - [2026-20727](https://policyrisk.com/federal-register/2026-20727): Medical Devices; Immunology and Microbiology Devices; Classification of the System for Detection of Nucleic Acid From Non-Viral Microorgani…, 2026-10-09 ## Sources - [2026-19660 on federalregister.gov](https://www.federalregister.gov/documents/2026/09/25/2026-19660/reauthorization-of-the-biosimilar-user-fee-act-public-meeting-request-for-comments) - [2026-19660 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2026-09-25/pdf/2026-19660.pdf) ## Related - [Previous: 2026-19659, Multifamily Housing Preservation Pilot and Multifamily Housing Guaranteed Loan…](https://policyrisk.com/federal-register/2026-19659) - [Next: 2026-19661, Combined Notice of Filings #1](https://policyrisk.com/federal-register/2026-19661) - [All Federal Register documents](https://policyrisk.com/federal-register) Source: PRIA, https://policyrisk.com/federal-register/2026-19660 (as of 2026-10-02).