Draft Guidance Issued on Biosimilars

US Pharm. 2012;37(4):44.

The FDA issued three draft guidance documents on biosimilars to assist the industry in developing these drugs in the U.S. The FDA is seeking public comment on the following documents: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product; Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product; and Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009.

“When it comes to getting new biosimilar products on the market, FDA has taken an innovative approach to supporting their development at every step of the process,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research. “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.”

The FDA will provide instructions on how to submit comments in an upcoming Federal Register notice.