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Alvotech Gets FDA Nod For Added US Manufacturing Capacity For Humira Biosimilar SIMLANDI, Doubling Drug Substance Capacity At Reykjavik Site

Benzinga·10/05/2026 08:23:02

Approval enables AVT02 drug substance for U.S. commercial supply to be manufactured in either of Alvotech’s two Reykjavik drug substance suites

Further confirms resolution of FDA inspection-related matters at the Reykjavik site