📋FDA Guidance on Biosimilar Classification Categories Released
Classification Categories for Certain Supplements Under Biosimilar User Fee Amendments III; Guidance for Industry; Availability
Summary
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 This guidance finalizes and replaces the draft guidance of the same title issued on August 11, 2023.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The regulatory text outlines classification categories for biosimilar supplements, impacting businesses by clarifying submission processes and review standards for applications. This guidance helps companies navigate regulatory requirements efficiently, which can affect compliance costs and time-to-market for biosimilar products.