On March 9, 2026, the U.S. Food and Drug Administration (FDA) issued new draft guidance aimed at further streamlining the development of biosimilar and interchangeable biosimilar products by reducing certain clinical pharmacokinetic (PK) study requirements when scientifically justified. The announcement builds on an earlier FDA initiative announced in October that sought to reduce certain comparative efficacy studies, which can take one to three years to complete and cost approximately $24 million. The agency estimates that the revised approach could reduce PK study costs by up to 50%, or approximately $20 million per development program. Together, these initiatives signal a continued shift toward a more streamlined, science‑based approach to biosimilar development.
The new draft guidance—“New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 4)”—revises and replaces the FDA’s September 17, 2021 draft guidance (Revision 3) and updates certain questions and answers from the agency’s prior final guidance addressing biosimilar development under the Biologics Price Competition and Innovation Act (BPCIA). Among the most notable changes, the draft guidance updates the FDA’s recommendations regarding the use of comparator products approved outside the United States. Specifically, the agency describes circumstances in which biosimilar applicants may rely on clinical data generated using a non‑U.S.-licensed comparator product without conducting an additional three‑way PK study comparing the proposed biosimilar, the U.S.-licensed reference product, and the non‑U.S.-licensed comparator. The guidance also removes the FDA’s prior recommendation that at least one clinical PK study directly compare the proposed biosimilar with the U.S.-licensed reference product, provided the applicant can scientifically justify reliance on an alternative comparator.
In connection with the issuance of the draft guidance, the FDA announced that it is withdrawing its April 2015 final guidance, “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product,” explaining that its scientific thinking has evolved since that guidance was issued, at a time when the agency had approved only one biosimilar application, and that the document no longer reflects the FDA’s current recommendations.
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