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CDER Conversations

CDER Conversation: Biosimilar User Fee Amendments Latest Implementation: BsUFA III

Biosimilars are FDA-approved biologic medications that are highly similar to and have no clinically meaningful differences from existing FDA-approved biologics, called reference products. Biosimilars are safe and effective treatment options for many illnesses such as chronic skin and bowel diseases (like psoriasis, irritable bowel syndrome, Crohn’s disease and colitis), arthritis, kidney conditions, and cancer. 

Sarah Yim, M.D., OND’s Office of Therapeutic Biologics and Biosimilars (OTBB) director, speaks about BsUFA III goals and activities and Steven Kozlowski, M.D., OPQ’s Office of Biotechnology Products director speaks about the Biosimilar Regulatory Science Program. 

More from Sarah Yim and Steven Kozowski

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