Industry presses FDA for biosimilars reforms ahead of BsUFA renewal

Industry groups are urging changes to the US Food and Drug Administration’s Biosimilar User Fee Amendments programme as talks begin on reauthorizing the scheme for another five years. BsUFA, which funds FDA’s biosimilar reviews through user fees, expires in September 2027 and will require new legislation to continue.

Comments submitted to the agency argue that aspects of the current programme are slowing biosimilar development and limiting competition. Stakeholders say regulatory processes have not kept pace with advances in analytical science or with the FDA’s own experience reviewing biosimilars over the past decade.

Several groups called for greater authority to be given to reviewers in the FDA’s Office of Therapeutic Biologics and Biosimilars. They argue that final approval decisions should sit with specialists focused on biosimilars, rather than clinicians in therapeutic-area offices who primarily review originator biologics.