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# Guide on Biosimilar User Fees
- URL: https://www.fdaweb.com/guide-on-biosimilar-user-fees/
- Published: 2023-07-28T12:00:00.000Z
- Updated: 2026-09-14T18:47:09.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5154983

FDA has posted a [final guidance](https://www.fda.gov/media/170634/download?ref=fdaweb.com) entitled “Assessing User Fees Under the Biosimilar User Fee Amendments (BUSFA 3) of 2022.” The document provides information on the types of user fees authorized by BsUFA 3, how FDA determines which products are subject to a fee, and FDA’s policies regarding exceptions and waivers. It also describes the process for submitting payments and the consequences for failing to pay, and the process for requesting reconsideration if a fee waiver request is denied.