At Last, Draft Biosimilars Guidance...Interchangeability, To Come?
By EVAN D. DIAMOND, PETRA SCAMBOROVA, ANTHONY MICHAEL, DAVID M. CONCA, & GERALD J. FLATTMANN
Yesterday, the U.S. Food and Drug Administration ("FDA") issued three long-awaited draft guidance documents regarding the abbreviated pathway for approval of for "biosimilar" therapeutic biologic products under the Biologics Price Competition and Innovation Act of 2009 ("BPCIA"):
- Scientific Considerations in Demonstrating Biosimilarity to a Reference Product("Scientific Considerations Guidance")
- Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product("Quality Considerations Guidance")
- Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009("Q&A Guidance")
These three documents (together, "Draft Biosimilars Guidance") provide general guidelines for companies seeking to file applications for licensure of biological products that are claimed to be "biosimilar" to existing approved biologics. See 42 U.S.C. § 262(k). While the Draft Biosimilars Guidance does not provide a one-size-fits-all or product-specific approach, it sets forth a stepwise, "totality of the evidence" process under which sponsors may submit information to FDA and consult with FDA to plan further studies based on the problems presented in each particular case.