FDA Releases Guidance On Biosimilar Approvals At Last

Law360, New York (February 9, 2012, 6:35 PM EST) -- The U.S. Food and Drug Administration on Thursday released much-awaited guidance for the biotech industry on how the agency will review biosimilars, the generic versions of biological drugs such as vaccines, blood cells and gene therapies.

To win approval, manufacturers must prove that their product is “biosimilar” to an existing FDA-approved biological product, meaning there are no “clinically meaningful differences” when it comes to safety, purity and potency. Biologics, usually derived from animal or human tissue, are much more complex than traditional pharmaceuticals, and the guidance...
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