FDA Eases Way For Gold-Standard Biosimilars

Law360 (May 10, 2019, 9:13 PM EDT) -- The U.S. Food and Drug Administration on Friday cemented its criteria for approving cream-of-the-crop biosimilars that pharmacies can automatically substitute in place of pricier biologics, simplifying standards it previously proposed and handing a badly needed win to the struggling biosimilars industry.

In final guidance, the FDA outlined its key considerations for deeming a biosimilar "interchangeable" with an innovator biologic. That's the gold standard to which all biosimilars aspire so they can be substituted at the pharmacy counter without a doctor's permission, just like traditional generic drugs.

"With this final guidance, I think we are closer to seeing the first interchangeable product out...

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