Gastroenterology

FDA creates final guidance on approval pathway for biosimilars



The FDA, as part of the Biosimilars Action Plan, is acting to promote competition in the biologic developer market by providing final guidance for “interchangeable” biologics on the pathway to approval, according to a release from the organization.
The FDA stated that its actions will clarify guidelines for developers who want to prove that their “interchangeable” biologics meet the statutory interchangeability standard under the Public Health Service Act.

“Today’s final guidance gives an overview of important scientific considerations in demonstrating

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