Today (31 July 2023) the United States Food & Drug Administration's Center for Biologics Evaluation and Research and Center for Drug Evaluation and Research released final guidance on "Assessing User Fees Under the Biosimilar User Fee Amendments of 2022".
BsUFA stands for the "Biosimilar User Fee Act" and is a legislation enacted by the United States Congress to authorize user fees for the review and approval of biosimilar products by the U.S. Food and Drug Administration (FDA).
The fees collected from biosimilar manufacturers help support the FDA's activities related to the review and regulation of biosimilar products, streamlining the approval process and facilitating timely access to safe and effective biosimilar medications for patients.
The BsUFA program plays a crucial role in fostering the development and availability of biosimilars in the U.S. market.
The purpose of this guidance is to inform stakeholders about the FDA's implementation of the Biosimilar User Fee Amendments of 2022 (BsUFA III) as part of the FDA User Fee Reauthorization Act of 2022, under Title IV.
The focus of this guidance is to elaborate on the user fees approved by BsUFA III, the FDA's criteria for determining which products are liable for such fees, and the agency's guidelines concerning exceptions and waivers.
Additionally, this guidance outlines the procedure for making payments to the FDA and the potential repercussions for non-payment of BsUFA fees. It also covers the process for requesting reconsideration in case the FDA denies a waiver or refund of user fees.
BsUFA III authorizes the collection of three types of fees:
Biosimilar biological product development program fees (BPD fees),
Biosimilar biological product application fees (application fees), and
Biosimilar biological product program fees (program fees).
The biosimilar biological product program fee (program fee) is assessed annually for each eligible biosimilar biological product. If a sponsor has failed to pay the annual BPD fee as required for a product for a period of two consecutive fiscal years, FDA may administratively remove the sponsor from the BPD Program for the product.
Check out this LINK to know more in detail about the program fees.
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