The FDA has introduced new draft guidance to streamline biosimilar development and reduce costs for manufacturers, marking another step in the agency’s ongoing effort to make biologic medicines more affordable.
The guidance recommends eliminating certain redundant clinical pharmacokinetic (PK) studies when scientifically justified, potentially reducing biosimilar PK testing expenses by up to 50%—an estimated $20 million per program. FDA Commissioner Marty Makary, M.D., M.P.H., said the move reflects the agency’s commitment to practical, science-based regulation that can help lower prescription drug costs for patients.
The draft guidance, New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 4), updates earlier recommendations issued in 2021. It allows developers to use clinical data from comparator products approved outside the U.S. without requiring additional three-way PK studies involving both U.S. and non-U.S. reference biologics—provided the approach is scientifically justified.
The announcement follows an earlier October 2025 FDA initiative that reduced the need for certain comparative efficacy studies, which can take several years and cost tens of millions of dollars.
As part of the update, the agency also withdrew the 2015 final guidance Scientific Considerations in Demonstrating Biosimilarity to a Reference Product, citing its evolution in scientific understanding after reviewing dozens of biosimilar applications.
Since establishing the biosimilar pathway under the Biologics Price Competition and Innovation Act of 2009, the FDA has approved 82 biosimilar products for conditions such as cancer, rheumatoid arthritis, and diabetes.
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