Biologics

Industry Recommendations for BsUFA 4 Reauthorization

At the 12/3/2025 public meeting on the BsUFA 4 reauthorization, several industry representatives presented their recommendations for matters to be considered in the reauthorization negotiations. CMC regulatory expert Fabiola Gomez (Hyman, Phelps & McNamara) outlines the recommendations in her firm’s FDA Law Blog.

The Biosimilar Forum urged a big-picture reauthorization goal focusing on:

improving development and process efficiency to decrease the costs of development;
ensuring stable and adequate resources for FDA’s scientific workforce; and
evaluating whether current paradigms, such as suffix naming conventions, remain necessary.

The Biosimilars Council (a part of the Association for Accessible Medicines) cited several areas for improvement:

shortened review timelines given decreasing reliance on comparative efficacy studies;
more efficient and transparent communication practices;
greater transparency and efficiency in the inspection process;
continued increased reliance on analytical data to streamline development;
enhanced approaches to device-related challenges (e.g., user interface differences and human factor studies, device bridging);
providing guidance for complex products such as antibody drug conjugates and bispecific monoclonal antibodies;
exploring using a single global comparator; and
strengthening the reauthorization framework to safeguard BsUFA-related resources and prevent disruptions.

Pharmaceutical Research and Manufacturers of America said BsUFA 4 should:

focus on core review functions to improve review times, ensure that review process enhancements introduced in earlier reauthorizations are used effectively and resources are used optimally, and improve engagement and communication between FDA and biosimilar applicants; and
enhance the program’s financial stability and sustainability by strengthening its financial structure to match FDA’s resource needs and simplifying the user fee revenue process to improve predictability.

In its opening presentation, Gomez says, FDA described several achievements under BsUFA 3 and said it was aware of the need to address challenges related to biosimilar development, manufacturing complexity, and the evolving landscape of biological products.

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