BsUFA IV Is Coming: What’s Next for U.S. Biosimilars? Key Takeaways from FDA’s December 2025 BsUFA Reauthorization Meeting

On December 3, 2025, the U.S. Food and Drug Administration held its public meeting on the upcoming reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years 2028–2032, known as BsUFA IV. The meeting gave regulators, manufacturers, and other stakeholders an opportunity to outline priorities for a program that now provides approximately 61% of FDA’s funding for biosimilars review activities and has supported the approval of 81 biosimilars to date.

For stakeholders, several themes emerged that will shape how biosimilars are developed, reviewed, and approved in the United States over the coming decade.

FDA Session – Opening Remarks and Background

FDA leadership emphasized that the biosimilars program continues to be a major driver of patient access and healthcare savings. Biosimilars have generated $56 billion in savings since 2015, including almost $20 billion in 2024 alone. Biosimilars lower costs in two ways: they enter the market at lower prices, and their presence also leads brand biologics to reduce prices, lowering overall spending.

FDA summarized BsUFA background, program performance, financial background and fee structure, as well as the reauthorization process.  FDA also described several BsUFA III achievements:

• New supplement categories, timelines and performance goals
• Review procedures of use-related risk analysis and human factors protocols for biosimilar combination products
• Launch of a regulatory science pilot program focused on advancing interchangeable biosimilar development
• New meeting types and follow-up clarification opportunities

At the same time, FDA is aware of the need to address the challenges related to biosimilar development, manufacturing complexity, and the evolving landscape of biological products. As the reauthorization process for BsUFA IV kicks off, FDA welcomes the participation of patients, consumer advocacy groups, industry, healthcare professionals, and scientific experts.

Industry Perspective Session

The Biosimilars Forum commended FDA’s collaboration with industry and urged a big-picture reauthorization goal focusing on:

• Improving development and process efficiency to decrease costs of development
• Ensuring stable and adequate resources for FDA’s scientific workforce
• Evaluating whether current paradigms (e.g., suffix naming conventions) remain necessary

The Forum emphasized the importance of taking a step back and looking at what should change to make BsUFA IV more efficient; because, even though better access is needed, biosimilars remain key to competition and cost savings.

The Biosimilars Council (Association for Accessible Medicines) highlighted the program’s substantial progress – such as FDA reducing the need for comparative efficacy studies – and presented several areas for improvement:

• Shortened review timelines in light of decreasing reliance on comparative efficacy studies
• More efficient and transparent communication practices
• Greater efficiency and transparency in the inspection process
• Continue the 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 (ADCs) and bispecific monoclonal antibodies
• Exploring the use of a single global comparator
• Strengthening the reauthorization framework in a way that safeguards BsUFA-related resources and prevents disruptions

The Pharmaceutical Research and Manufacturers of America (PhRMA) emphasized the need to preserve and build on the successes of previous BsUFAs and for the biosimilars review process to continue to be consistent, predictable, transparent, as well as independent and science-based.  In their view, BsUFA IV should:

• Focus on core review functions, for example:
  • Improving review times

• • Ensuring that review process enhancements introduced in prior BsUFA cycles are utilized effectively and resources used optimally
  • Improve engagement and communication between FDA and biosimilar applicants
• Enhance the financial stability and sustainability of the program by:
  • Streamlining the program’s financial structure to match the FDA’s resource needs
  • Simplifying the user fee revenue process to improve predictability

Public Comment Session

Teva Pharmaceuticals appreciated FDA’s role in fostering a robust and competitive biosimilars market and acknowledged the progress made in BsUFA III. However, from Teva’s perspective, several review process issues warrant attention, for example:

• Supplement review times
• Information requests and deficiency response timelines
• Information requests and labeling comments late in the review process.

Teva expressed looking forward to discussing the possible changes that could address these challenges such as i) earlier identification of deficiencies and earlier inspection scheduling and ii) enhanced oversight of where BsUFA funds are dedicated.

Regarding final approval oversight, because the FDA is moving away from requiring Phase III-style confirmatory clinical trials for biosimilars, Teva recommended that the office most directly involved in reviewing biosimilar applications have final approval authority. That is, granting the Office of Therapeutic Biologics and Biosimilars (OTBB) signatory authority would simplify administrative complexity and reduce the involvement of the Office of New Drugs (OND) clinicians in the final sign off of biosimilar applications, allowing the clinicians to focus on reviewing innovative (i.e., non-biosimilar) drugs.

What Comes Next?

Formal negotiations for BsUFA IV begin in Spring 2026 and are expected to conclude by Summer 2026. FDA must:

• Obtain clearance for the recommendations from the various layers of federal government
• Conduct a final public meeting towards the end of 2026
• Submit final BsUFA IV recommendations to Congress by January 15, 2027

Notably, for the first time in the BsUFA program, FDA will conduct monthly periodic meetings with patient and consumer groups to obtain their input on BsUFA IV. These meetings will be conducted in parallel during the FDA-Industry negotiation meetings.

In addition, due to a new requirement, FDA will post public minutes of the FDA-Industry negotiation meetings within 30 days after each meeting.

For stakeholders interested in participating in the consultation process:

• The public comment docket for the Initial Public Meeting remains open until January 2, 2026.
• Patient and consumer groups can sign up by email BSUFAReauthorization@fda.hhs.gov by January 30th, 2026.

Conclusion

The December 2025 meeting demonstrated broad consensus on the need for a biosimilars program that is efficient, scientifically current, predictable, and sustainably funded. As biosimilars continue to play an increasingly significant role in the American health care system, BsUFA IV will be critical in shaping the regulatory environment that governs their development and approval.

For stakeholders, the upcoming negotiation cycle offers an opportunity to help define how FDA’s biosimilar review program evolves over the next five years.

Stay tuned for more updates!