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  1. Biosimilar User Fee Amendments

Public | Virtual

Event Title
Public Meeting on the Reauthorization of the Biosimilar User Fee Act (BsUFA)
November 19, 2020

November 19, 2020


The Food and Drug Administration (FDA or Agency) held a public meeting on the reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years (FYs) 2023 through 2027. BsUFA authorizes FDA to collect user fees to support the process for the review of biosimilar biological products.  The current legislative authority for BsUFA expires in September 2022.  At that time, new legislation will be required for FDA to continue collecting user fees in future fiscal years. FDA begins the BsUFA reauthorization process by publishing a notice in the Federal Register requesting public input and holding a public meeting to hear stakeholder views as we consider the next BsUFA. For more background information or to submit comments, please see the Federal Register notice with assigned docket FDA-2015-N-3326.


This meeting was held in virtual format only, at https://collaboration.fda.gov/bsufanov2020/. Registration was available at this link on Eventbrite.

The meeting recording can be accessed at https://collaboration.fda.gov/ptnqmlycvlft/.


Emily Ewing, Emily.Ewing@fda.hhs.gov, Center for Drug Evaluation and Research, Food and Drug Administration

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