Industry and FDA Reach Impasse Over Reference Product Exclusivity in BsUFA IV Negotiations

US Food and Drug Administration (FDA) officials and pharmaceutical industry representatives have failed to reach an agreement on reference product exclusions (RPE) during negotiations for the reauthorization of the Biosimilar User Fee Act (BsUFA IV). The disagreement centers on the number of annual RPE determinations the agency will make, which industry leaders argue is essential for long-term portfolio management and pipeline planning. This impasse highlights ongoing tensions regarding regulatory certainty and the financial burden of user fees for biosimilar developers as the program prepares for the 2028–2032 fiscal cycle.

During a May 12 meeting attended by 22 FDA officials and 15 industry representatives, the two sides discussed the reauthorization of BsUFA IV for fiscal years 2028 through 2032. The primary point of contention involves reference product exclusions, which exempt specific classes of biological products—such as blood components for transfusion, allergenic extracts, and certain IV fluids—from biosimilar user fees. While the current law does not specify the number of products qualifying for these exclusions, industry representatives asserted that the FDA’s counterproposal failed to address their challenges regarding regulatory uncertainty, which they claim can deter and delay product development.

The FDA expressed a willingness to publish a limited, unspecified number of RPE determinations annually, but insisted these selections remain at the agency's discretion. Industry representatives countered that this approach is insufficient and requested a formal process where applicants could request determinations based on established timelines. However, the FDA warned that without limitations, the agency could be overwhelmed by requests, noting that RPE determinations involve complex legal and policy issues that are difficult to manage even with increased resources. The agency suggested that the issue might not be addressable within the formal Commitment Letter.

Beyond RPE, the parties also clashed over the proposed inter-center consultative review process (ICCR). Industry sought explicit language ensuring that all FDA centers and divisions involved in consultations adhere to the specific BsUFA timelines. The FDA declined to adopt this language, stating that adherence to these timelines is already implied in existing user fee acts, including the Prescription Drug User Fee Act (PDUFA). As the negotiations for BsUFA IV continue, the industry plans to provide further details on a counterproposal to resolve the RPE impasse, which remains a critical factor for the financial and strategic planning of biosimilar manufacturers.