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Biosimilars Law Blog

Tag Archives: biosimilarity

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

Posted in News & Events

The First Biosimilar in the U.S. – Five Questions Left Open by FDA

Last month, the Food and Drug Administration (FDA) approved the first U.S. biosimilar, Zarxio (filgrastim-sndz). Since the positive vote of FDA’s Oncologic’s Drugs Advisory Committee at its January meeting, approval of Sandoz’s biosimilar to Amgen’s Neupogen for all 5 Neupogen indications was anticipated. This landmark event comes almost exactly 5 years after passage of the

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