The US Food and Drug Administration’s (FDA’s) February 2026 announcement, made public in the New England Journal of Medicine (NEJM), outlines that one adequate and well-controlled pivotal study, together with confirmatory evidence, will now be the agency’s default basis for product approval. This differs from the FDA’s previous general expectation of two independent, adequate, and well-controlled pivotal trials to demonstrate substantial evidence of effectiveness.

An overview of the key regulatory intelligence updates from FDA & EMA released in 2025.

FDA’s draft guidance streamlines biosimilar approval by reducing the need for comparative efficacy studies (CES). The guidance provides revised criteria outlining the circumstances in which conducting CES may be unnecessary for a Biologics License Application submitted through the 351(k) biosimilar and interchangeable biosimilar pathway.