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.
- Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product. Final 4/28/15.
- Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009. Final 4/28/15.
- Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009. Draft 5/12/15.
A list of current versions of all biosimilars guidances is readily accessible on FDA’s web site.