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FDA Updates U.S. Biosimilar Guidances

Marie A. Vodicka

Marie A. Vodicka,

Washington, D.C.

23 June 2015
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.
Marie A. Vodicka

Marie A. Vodicka,

Washington, D.C.

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