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Alvotech gets new FDA review for Humira biosimilar

Thread starter cafead
Start date Sep 20, 2023

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cafead

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cafead Sep 20, 2023 at 11:22: PM

via The Food and Drug Administration is reviewing Alvotech’s newest application for its Humira biosimilar, setting a Feb. 24 deadline to decide on approval, the company said Wednesday. The regulator has twice rejected the drug because of manufacturing issues at an Iceland plant.

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