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 FDA | CDER | Small Business and Industry Assistance
INDUSTRY NEWS
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Request for Patient and Consumer Advocacy Group Participation in BsUFA Reauthorization Stakeholder Consultation Meetings
The FDA is inviting patient and consumer advocacy groups to participate in periodic consultation meetings on the reauthorization of the Biosimilar User Fee Act (BsUFA). BsUFA authorizes FDA to collect user fees from the regulated industry to support the process for the review of biosimilar biological products (biosimilars). The authorization for the current program (BsUFA III) expires in September 2027 and these meeting will be held monthly throughout the negotiation process, beginning in April 2026.
FDA is issuing this Federal Register notice to request that representatives from patient and consumer advocacy groups notify FDA of their intent to participate in the periodic stakeholder consultation meetings on BsUFA reauthorization.
FDA believes that consistent stakeholder representation at these meetings will be important to ensure progress in these discussions. If you wish to participate in these stakeholder consultation meetings, please designate one or more representatives from your organization who will commit to attending these meetings and preparing for the discussions. Stakeholders who identify themselves through this notice will be included in all patient and consumer advocacy group stakeholder consultation discussions while FDA negotiates with the regulated industry.
These meetings represents a key opportunity for patient and consumer advocacy groups to contribute to the development of the next five-year biosimilar user fee program. For more information on how to notify FDA of your intent to participate, see the Federal Register Notice.
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The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research provides guidance, education and updates for regulated industry.
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