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Biosimilars Law Blog

Monthly Archives: June 2015

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. Scientific Considerations Demonstrating Biosimilarity to a Reference Product. Final 4/28/15. Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein