U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. Assessing User Fees Under the Biosimilar User Fee Amendments of 2022
  1. Search for FDA Guidance Documents

GUIDANCE DOCUMENT

Assessing User Fees Under the Biosimilar User Fee Amendments of 2022 Guidance for Industry July 2023

Download the Final Guidance Document
Final Level 2 Guidance
Docket Number:
FDA-2017-D-6209
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research
Center for Drug Evaluation and Research

This guidance provides information to stakeholders regarding FDA’s implementation of the Biosimilar User Fee Amendments of 2022 (BsUFA III) under Title IV of the FDA User Fee Reauthorization Act of 2022.

This guidance describes the types of user fees authorized by BsUFA III, how FDA determines which products are subject to a fee, and FDA’s policies regarding exceptions and waivers.  This guidance also describes the process for submitting payments to FDA and the consequences for failing to pay BsUFA fees, and the process for requesting reconsideration if FDA denies a request for a waiver or return of user fees.

Submit Comments

Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2017-D-6209.

Back to Top