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.
