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Biosimilars Law Blog
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FDA Anticipates New Draft Biosimilar Guidances

Including biosimilars in the release of expected 2014 CDER draft guidance documents has sparked the public interest as industry, physicians, patients and others await additional cues on FDA’s implementation of the BPCIA.  The Center for Drug Evaluation and Research’s 2014 agenda for new and revised draft guidances includes the following for Biosimilars:

  • Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009
  • Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product
  • Considerations in Demonstrating Interchangeability to a Reference Product
  • Labeling for Biosimilar Biological Products
  • Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act

Except for the “Additional Questions and Answers” guidance, these are not updates to the previously released draft guidances from March 2012.  These are entirely new topics not yet addressed for implementation of the biosimilars pathway.   With their publication will come additional opportunities for public input.