FDA Continues to Expedite Biosimilar Development
Alex Brill and Christy Robinson
Following its move in October to eliminate comparative efficacy studies for biosimilars in development, last week the FDA made further strides to streamline the biosimilar approval process in the United States. In new draft Q and As providing guidance for the industry, the agency updated its stance to allow a biosimilar sponsor to use comparative clinical data from a non-US biosimilar’s pharmacokinetic (PK) testing in seeking FDA approval of a biosimilar. According to the FDA, eliminating the need for PK testing of a biosimilar, where scientifically justified, would save roughly $20 million in development costs.
In an MGA white paper last March, we highlighted the lack of global comparability as an impediment to the US biosimilars market. Needless to say, we are pleased with the development, the banner year the FDA had in biosimilar approvals in 2025, and the continued progress the agency is making on the biosimilars front.
