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Biosimilars Law Blog

Tag Archives: interchangeability

Posted in News & Events

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Including biosimilars in the release of expected 2014 CDER draft guidance documents has sparked the public interest as industry, physicians, patients and others await additional cues on FDA’s implementation of the BPCIA.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

Posted in News & Events

Awaiting FDA Guidance on Interchangeability for Biosimilars

The three draft Guidances recently released by the U.S. Food and Drug Administration on implementation of the Biologics Price Competition and Innovation Act of 2009 focus on how to demonstrate biosimilarity but don’t say much about demonstrating interchangeability.  FDA has asked for stakeholder input on biosimilar interchangeability at the agency’s upcoming one-day public hearing on