FDA Proposed Overhaul for Biosimilar Regulatory Program
The proposed BsUFA IV agreement aims to streamline supplement reviews and eliminate specific development fees by 2027.
Updated on Sept. 28, 2026 in Biotech
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The FDA has published a proposed commitment letter for the Biosimilar User Fee Act (BsUFA) IV, a program overhaul designed to improve regulatory efficiency. The plan introduces structural changes to application fees and review timelines for biosimilar products.
Why it matters
These changes are intended to accelerate the drug approval process by consolidating supplement categories and eliminating various development fees. The proposal shifts the regulatory framework ahead of the current program's expiration in September 2027.
The FDA aims to target 90% of biosimilar supplements for review within new 4-month and 6-month goals. This replaces the previous six-category system with two streamlined classifications.
The players
Food and Drug Administration
The federal agency responsible for overseeing the safety and efficacy of food, drugs, and biologics in the United States.
The details
The proposal eliminates initial, annual, and reactivation biosimilar product development fees while introducing a tiered application fee for sponsors with multiple biologics license applications. To resolve late-arising review issues, the FDA is introducing an imminent action mechanism. Additionally, the agency will replace existing Biosimilar Initial Advisory meetings with more structured Type 2b meetings.
Timeline
9 June 2026: Industry and FDA reached an impasse on exclusivity.
13 August 2026: FDA outlined PDUFA VIII commitment letter goals.
25 September 2026: The FDA issued the commitment letter notice.
26 October 2026: The FDA holds a public meeting.
September 2027: The current BsUFA III program authorization expires.
The Tech Race
This proposal marks a departure from the Biosimilar User Fee Act (BsUFA) III, which currently governs industry funding and agency review standards. The changes align with broader efforts to transition toward a more efficient, tiered review process before the existing authorization lapses.
The consolidation of review categories and fee structures is expected to simplify the regulatory path for manufacturers seeking biosimilar approval. Stakeholders should monitor upcoming guidance regarding new pediatric study plan templates for biosimilar products.
The takeaway
The FDA's proposed changes reflect an attempt to prioritize efficiency by removing redundant development fees and consolidating complex review pathways. Watch for the public feedback session in October and upcoming guidance regarding pediatric study plan requirements.
What happens next
The FDA will hold a public meeting on 26 October 2026 to discuss the proposed changes to the program.
Further reading
For more on the current regulatory landscape, explore Biotech.
Source note: This article includes information reported by Raps.
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