FDA Issues Draft Guidance on Biosimilar Product Development

February 15, 2012 5:39 pm

Food and Drug Administration (FDA) has issued three draft guidance documents on biosimilar product development to assist industry in developing such products in the US, as reported in an FDA news release. Janet Woodcock, MD, director of FDA’s Center for Drug Evaluation and Research stated that “These draft documents are designed to help industry develop biosimilar versions of currently approved biological products, which can enhance competition and may lead to better patient access and lower cost to consumers.” FDA explains that through the new approval pathway, biological products are approved based on demonstrating they are biosimilar to, or interchangeable with, a biological product that is already approved by FDA, which is called a reference product. The three guidance documents are available for download from the FDA Web site:

•  Scientific Considerations in Demonstrating Biosimilarity to a Reference Product (PDF)
•  Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product (PDF)
•  Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of    2009 (PDF)

FDA will seek public comment on the guidance documents and instructions on how to submit comments will be announced in an upcoming Federal Register notice. In finalizing the guidance documents, the agency will consider the information received from the public.

Background on the development of the FDA approval pathway for biosimilar products is presented in two NABP Newsletter articles:

•  “Paving Approval Pathway for Biosimilars Presents Unique Challenges for FDA,” April 2011 NABP Newsletter.
•  “FDA to Release Guidance Document on Approval Pathway for Biosimilars,” November-December 2011 NABP Newsletter.