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Biosimilars Law Blog
Posted in News & Events

FDA Updates U.S. Biosimilar Guidances

Five years after enactment of the BPCIA and following its first biosimilar approval, the U.S. Food and Drug Administration finalized its initial guidances describing the scientific and regulatory expectations for biosimilar approval under the 351(k) pathway.

A list of current versions of all biosimilars guidances is readily accessible on FDA’s web site.