The U.S. Food and Drug Administration has announced significant action to make it faster and less costly to develop biosimilar medicines, which are lower-cost "generic" alternatives to biologic drugs that treat serious and chronic diseases.
In a new draft guidance, the FDA proposes major updates to simplify biosimilarity studies and reduce unnecessary clinical testing. The agency said that through a separate initiative, it also plans to make it easier for biosimilars to be developed as interchangeable with brand-name biologics, helping patients and pharmacists choose lower-cost options more easily.
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by Joji Xavier
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