Transcription of FDA perspectives: Biosimilar Development with a …
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FDA perspectives: Biosimilar Development with a …
Steven Kozlowski, Director, Office of Biotechnology Products OPS/CDER / FDA FDA/PQRI Conference on Evolving Quality North Bethesda, MD September 17th, 2014 FDA perspectives: Biosimilar Development with a Lens on Quality The Biologics Price Competition and Innovation Act (BPCI Act) was passed as part of healthcare reform (Affordable Care Act) that President Obama signed into law on March 23, 2010. The BPCI Act creates an abbreviated licensure pathway for biological products shown to be Biosimilar to or interchangeable with an FDA-licensed reference product. Statute Overarching Goal: Efficient, predictable and transparent regulatory pathway Draft Guidances Feb 2012 Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants (March 2013) Draft Guidances Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product (May 2014) Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act (Aug)
4. Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants (March 2013) Draft Guidances 5. Clinical Pharmacology Data to Support a
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