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  1. Biosimilar User Fee Amendments

BsUFA IV: Fiscal Years 2028-2032

On September 30, 2022, the President signed into law the FDA User Fee Reauthorization Act of 2022. This new law includes the second reauthorization of the Biosimilar User Fee Act (BsUFA) that provides FDA with the necessary resources to maintain a predictable and efficient review process for biosimilar biological products. The current legislative authority for BsUFA III expires in September 2027. At that time, new legislation will be required for FDA to continue collecting biosimilar user fees in future fiscal year to fund the process for reviewing biosimilar biological products.

Information related to FDA’s preparation for the fourth reauthorization of BsUFA will be posted on this page as it becomes available.

BsUFA III Reauthorization Kickoff Public Meeting – December 3, 2025

The Food and Drug Administration held a public meeting on December 3, 2025 to kick off the process for reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years 2028- 2032

Industry and Stakeholder Discussions on Reauthorization

FDA will develop proposed enhancements for BsUFA IV in consultation with drug industry representatives and public stakeholders, including patient and consumer advocates. The notes from FDA’s discussions with industry and other stakeholders will be posted on this webpage as they become available.

Industry Discussions on Reauthorization

DateTopics
6/18/2026Approach to Supplements Draft Commitment Letter Language; Approach to Modernizing BLA Review Draft Commitment Letter Language; Approach to Meeting Management Draft Commitment Letter Language; Approach to Third-Party Assessment Draft Commitment Letter Language; Approach to Imminent Action (IA) Draft Commitment Letter Language; Approach to Combination Products Draft Commitment Letter Language; Approach to Provisional Determinations (PD) Draft Commitment Letter Language; Approach to BsUFA IV Reporting Commitments; Next Steps
6/16/2026Approach to Draft Facility Inspections Commitment Letter Language; FDA Data Fidelity Proposal Follow Up; Approach to Draft Modernizing BLA Review Commitment Letter Language; Approach to BsUFA IV Draft Commitment Letter; Approach to Draft Third-Party Assessment Commitment Letter Language; Approach to Supplements Draft Commitment Letter Language; Next Steps
5/27/2026Approach to Draft Pediatric Research Equity Act (PREA) Commitment Letter Language; Approach to Draft Supplements Commitment Letter Language; FDA Feedback on Industry Imminent Action (IA) Counterproposal; FDA Counterproposal to Industry’s Modernizing BLA Review – Approved BLAs Transparency Proposal; FDA Revised Provisional Determinations (PDs) Proposal; BsUFA IV Negotiations Progress Check; Next Steps
4/7/2026Expectations and Ground Rules; BsUFA Program Overview; FDA Proposal Presentation; Industry Proposal Presentation; Next Steps
4/9/2026Proposal Schedule; FDA Supplements Proposal; Industry Supplements Proposal; Industry Pediatric Research Equity Act (PREA) Proposal; Next Steps
4/14/2026FINANCE: Common Themes - Kickoff and Proposals; BsUFA Program Overview; BsUFA Proposal Inventory; Next Steps
4/14/2026Proposal Schedule; Industry Biologic Device Combination Products Proposal; Industry Intercenter Consultative Review (ICCR) Process Proposal; FDA Meeting Management Proposal; Industry Meeting Management Proposal; Next Steps
4/16/2026Supplements Proposal Discussion; FDA Counterproposal for Pediatric Research Equity Act (PREA) Proposal; Industry Investigational New Drug (IND) Protocols; Next Steps
4/21/2026Industry Response to FDA Pediatric Research Equity Act (PREA) counterproposal; FDA Data Fidelity Proposal; FDA Provisional Determinations (PDs) Proposal; Industry Exclusivity Determinations Proposal; FDA Imminent Action (IA) Proposal; Industry Labeling Proposal; Industry Risk Evaluation and Mitigation Strategies (REMS) Proposal; Next Steps
4/23/2026FDA Combination Products and Inter-Center Consultative Review (ICCR) Counterproposal; FDA Investigational New Drug (IND) Protocols Proposal Response; Industry Meeting Management Proposal Clarification; Next Steps
4/30/2026FINANCE: Spending Trigger Details; Revenue Framework Proposals; Other Proposals; Next Steps 
4/28/2026Regulatory Science Proposals; Industry Late Cycle Meeting (LCM) Proposal; Industry Modernize BLA Review Subproposals; Next Steps
4/30/2026Follow-Up Discussion on Supplements; Human Factors Considerations for Supplements and Combination Products; FDA Meeting Management Counterproposal; FDA Meeting Management Proposal Clarification; Next Steps
5/5/2026BsUFA IV Negotiations Progress Check; FDA Provisional Determinations (PD) Proposal; FDA Exclusivity Determinations Counterproposal; Approach to Draft Regulatory Science Commitment Letter Language; FDA IND Protocols Response; Facility Inspections Proposals; Next Steps
5/7/2026FDA Imminent Action (IA) Proposal; FDA Enhancing Review Efficiency and Modernizing BLA Review Counterproposal; Approach to Draft Regulatory Science Commitment Letter Language; Next Steps
5/7/2026FINANCE: BsUFA Finance Primer; Fee Setting Process; Fee Structure Proposals and Fee Setting Demo; Application Fee Differentiation Based on Comparative Effectiveness Study (Industry Proposal); Single Application Fee with Half Fee for Simultaneous Secondary BLAs (FDA Proposal); Eliminate the Biosimilar Product Development (BPD) Fee (Industry Proposal); Next Steps
5/12/2026Stakeholder Meeting Summary; FDA Data Fidelity Proposal; FDA Modernizing Biologics License Application (BLA) Review Counterproposals; Industry Exclusivity Determinations Proposal; Industry Inter-center Consultative Review (ICCR) Proposal; BsUFA IV Negotiations Progress Check; Next Steps
5/14/2026FINANCE: OR TRR and Enhanced Reporting; Continued Proposal Discussion: Operating Reserve (Industry Proposal); Continued Proposal Discussion: Fee Structure (Industry and FDA Proposals); Proposal Progress Check; Next Steps
5/14/2026Approach to Draft Regulatory Science Commitment Letter Language; FDA Imminent Action (IA) Proposal; FDA Counterproposal to Industry’s Modernizing BLA Review – Major Amendments Proposal; FDA Meeting Management Proposal Clarification; Next Steps
5/19/2026Approach to Draft Regulatory Science Commitment Letter Language; Facility Inspections Proposals; Approach to Draft Investigational New Drug (IND) Protocols Commitment Letter Language; Approach to Draft Pediatric Research Equity Act (PREA) Commitment Letter Language; Approach to Draft Third-Party Assessment Commitment Letter Language; Approach to Draft Supplements Commitment Letter Language; Industry Exclusivity Determinations Counterproposal; BsUFA IV Negotiations Progress Check; Next Steps
5/21/2026Approach to Industry’s Exclusivity Determinations Proposal; FDA Imminent Action (IA) Proposal; FDA’s Revised Provisional Determination (PD) Proposal; FDA Counterproposal to Industry’s Modernizing BLA Review – Approved BLAs Transparency Proposal; Approach to Draft Pediatric Research Equity Act (PREA) Commitment Letter Language; Next Steps
5/21/2026FINANCE: OR TRR and Enhanced Reporting; Operating Reserve; Fee Structure Counter from Industry; Technical Meeting Language; Next Steps
5/27/2026FINANCE: Resource Ledger; Operating Reserve; Fee Structure; OR TRR and Enhanced Reporting; America First Small Business Waiver; Technical Meeting; Next Steps
6/9/2026Approach to Draft Combination Products Commitment Letter Language; FDA Risk Evaluation and Mitigation Strategies (REMS) Counterproposal; Approach to Draft Facility Inspections Commitment Letter Language; Approach to Draft Third-Party Assessment Commitment Letter Language; Industry Modernizing BLA Review Proposal Follow Up; Industry Response to FDA Provisional Determinations (PDs) Proposal; BsUFA IV Negotiations Progress Check; Stakeholder Meeting Summary; Next Steps
6/11/2026FINANCE: Resource Ledger; OR TRR Follow Up Questions; Review Draft Language; Next Steps
6/11/2026Approach to Imminent Action (IA) Draft Commitment Letter Language; Approach to Meeting Management Draft Commitment Letter Language; Approach to Supplements Draft Commitment Letter Language; Approach to BsUFA IV Draft Commitment Letter; Negotiations Progress Check-In; Modernizing Biologics License Application (BLA) Review Proposal Discussion; Next Steps

Stakeholder Discussions on Reauthorization

DateTopics
4/27/2026BsUFA Reauthorization Overview and Program Background; BsUFA IV Public Stakeholder Perspectives Summary; Identifying Priority Meeting Series Topics (Open Discussion and Poll); Next Steps
5/29/2026Biosimilar and Interchangeable Products; Regulatory Science Pilot Program; Finance and Staffing; Next Steps
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