> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Biosimilar User Fees Info Collection Revised
- URL: https://www.fdaweb.com/biosimilar-user-fees-info-collection-revised/
- Published: 2025-01-31T12:00:00.000Z
- Updated: 2026-09-14T14:52:12.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5158583

*Federal Register* notice: FDA has submitted to OMB an information collection revision entitled “Biosimilars User Fee Program.” The document supports the agency’s biosimilar review and user fee program that allows an abbreviated approval pathway for biological products shown to be biosimilar to or interchangeable with an FDA-licensed reference biological product. The collection is being revised to reflect the currently agreed-upon performance goals established and captured in the latest reauthorization document entitled, “Biosimilar Biological Product Reauthorization Performance Goals and Procedures Fiscal Years 2023 Through 2027.” To view the notice, click [here](https://public-inspection.federalregister.gov/2025-02153.pdf?ref=fdaweb.com).