Biosimilar User Fee Act (III) performance goals letter published

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In mid-September 2021, the US Food and Drug Administration (FDA) released the Performance Goals Letter for the Biosimilar User Fee Act (BsUFA) III (FY2023 – FY2027) [1].

User Fee V13H23

The BsUFA was first authorized in 2012 and forms part of the Food and Drug Administration Safety and Innovation Act (FDASIA). Through the collection of fees from companies that are developing biosimilar and interchangeable products, this helps provide FDA with resources and staffing to support and improve the biosimilar approval pathway. Overall, it aims to help make therapies available to patients sooner without compromising on safety, efficacy and quality [2].

BsUFA II (FY2018 – FY2022) was informed by lessons learned from initial experiences with the programme. This included enhancements to the biosimilars review process through improved communications during the biosimilars review process; a new time reporting system, improved financial transparency and improved recruitment, hiring and retention of staff [2].

Now, the performance goals letter has outlined the key provisions of BsUFA III. These include:
Advancing development of interchangeable biosimilar products. This encompasses components related to research and the development of new products, which will leverage a Regulatory Science Program, to also assist in regulatory decision-making, and support guidance development.
Commitments to timelines for review of some application supplements. For example, those seeking to update safety labelling to reflect changes to the reference product labelling. In addition, to provide enhanced consistency and predictability of review timelines.
 Enhancing manufacturing inspection-related communications and modernizing facility assessment approaches.
Modernizing FDA’s information technology infrastructure and supporting adoption of cloud-based technologies.
Enabling timely interactions between sponsors and FDA during biosimilar development and review. This will include developing a new meeting type for rapid, targeted feedback.
Enhancing FDA hiring, retention and financial management.

A virtual public meeting to discuss the proposed enhancements for the reauthorization of BsUFA III is to be held on 2 November 2021.

Related articles
FDA increases transparency of biosimilar applications

FDA issues new guidance on biosimilar user fees


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1. U.S. Food and Drug Administration. Biosimilar biological product authorization performance goals and procedures for fiscal years 2023 through 2027 [homepage on the Internet]. [cited 2021 Oct 22]. Available from:
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilar User Fee Act reauthorization []. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Oct 22]. Available from:

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