Amidst the Trump administration’s efforts to reduce FDA and Health and Human Services Department staffing, there was concern regarding the agency’s ability to maintain its published schedule for approvals and biosimilar licensing application processing. There was hope the industry would be spared the effects of the administration’s cutbacks, because the program is largely self-funded: The biosimilar manufacturers pay for the FDA biosimilar approval process and staffing through its submission of biosimilar user fees (BsUFA).
The FDA has generally maintained the BsUFA III schedule, and the pace of application reviews and approvals seem to be on track for this calendar year. However, would the FDA hold BsUFA fee rates steady in the face of lower agency funding and staffing?
The answer seems to be yes. And the FDA has announced that certain fees for fiscal year 2026 will actually be a bit lower relative to the fees for fiscal year 2025. For example, the initial biosimilar product development fee and the annual fee will remain the same at $10,000. Reactivation of an existing product development program remains static at $20,000. However, the application fees have actually decreased. For 351(k) applications incorporating clinical data the fee has dropped by nearly $275,000 to $1.2 million. In the case of applications that the FDA has determined do not require clinical data, the fee is roughly half, at $600,000—a drop of 18% from FY 2025. The annual program fee has also been reduced 18% to $209,000.
Bio-Thera and STADA Partnership in Europe
On the European front, Germany-headquartered STADA Arzneimittel AG and China-based Bio-Thera Solutions announced a new agreement for the commercialization of tocilizumab. Under the terms of the agreement, which was announced August 22, Bio-Thera will be responsible for developing and manufacturing the tocilizumab biosimilar and STADA will have exclusive rights to commercialize the agent in the European Union, United Kingdom, and selected other countries. In the United States, Bio-Thera’s tocilizumab biosimilar (Tofidence) is marketed by Organon. STADA and Bio-Thera have an existing marketing partnership for BAT2506, a golimumab biosimilar candidate.
