Outside Publication

FDA Biosimilar Policy: 3 Documents, 1 Key Theme, Law360

May 12, 2015

On April 28, 2015, three years after the initial draft biosimilar guidance documents were issued, the U.S. Food and Drug Administration released final biosimilar guidance documents.

The final biosimilar guidance documents mirror the initial drafts and consist of the following three documents: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product; Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product; and a Q&A Regarding Implementation of the Biologics Price Competition and Innovation Act ("BPCI Act") of 2009.

Throughout each of the three guidance documents, the FDA emphasizes its recommendation that potential biosimilar applicants meet early and often with the FDA during their development of a biosimilar. 

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