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FDA Issues Updated Framework for Biosimilar Reviews
On Wednesday, Oct. 29, the Food and Drug Administration (FDA) issued draft guidance proposing to update its biosimilar review framework. Under the new approach, most biosimilar applications will no longer require comparative efficacy studies (CES) if pharmacokinetic and immunogenicity data show the product is biosimilar to its reference biologic. For many biosimilars, this will pave the way for approval without a costly clinical efficacy trial….
By: Brownstein Hyatt Farber Schreck