Health Law Daily Wrap Up, DRUGS AND BIOLOGICS—FDA GUIDANCE NOTICES: New guidance helps applicants identify appropriate classification categories for biosimilars, (Sep 9, 2025)

By WK Editorial Staff

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Classification Categories for Certain Supplements Under BsUFA III.”

This guidance provides recommendations for applicants on classification categories A, B, C, D, E, and F for original and resubmitted prior approval supplements submitted to approved applications for biosimilar and interchangeable biosimilar products under the Public Health Service Act (PHS Act). The commitment letter associated with the Biosimilar User Fee Amendments of 2022 (BsUFA III) sets forth these supplement classification categories and their associated review performance goals. This guidance is intended to help applicants identify the appropriate classification category and review goal date of the supplement being submitted. This guidance finalizes and replaces the draft guidance of the same title issued on August 11, 2023. (Notice, 90 FR 43454, September 9, 2025).

Dates. The announcement of the guidance is published in the Federal Register on September 9, 2025.

FederalRegisterIssuances: FDAGuidanceNotices FDCActNews DrugBiologicNews