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# New Biosimilar User Fees Explained
- URL: https://www.fdaweb.com/new-biosimilar-user-fees-explained/
- Published: 2018-06-28T12:00:00.000Z
- Updated: 2026-09-15T00:16:55.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141789

FDA has issued a guidance, *Assessing User Fees Under the Biosimilar User Fee Amendments of 2017*, to give stakeholders information on the agency’s implementation of the Biosimilar User Fee Amendments of 2017 (BsUFA 2). The [document](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM584984.pdf?ref=fdaweb.com) describes the types of user fees authorized by BsUFA 2, the process for submitting payments to the agency, the consequences for failing to pay BsUFA fees, and the process for requesting a reconsideration of a user fee assessment.

The guidance also describes how FDA determines which products are subject to a fee and discusses changes to agency policy under the new law. It does not address how FDA determines and adjusts fees each fiscal year, nor does it address the agency’s implementation of other user fee programs such as PDUFA or GDUFA.

Included in the guidance are Introduction, Background, Definitions, Changes to the Structure of the BsUFA User Fee Program, Biosimilar Biological Product Development Fees, Biosimilar Biological Product Application Fees, Biosimilar Biological Product Program Fees, Failure to Pay Fees, Payment Information and Procedures, Appeals Process, and Other Resources.