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Alvotech Wins US FDA Nod for New Humira Biosimilar Manufacturing Process

MT Newswires·10/20/2026 05:34:40
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05:34 AM EDT, 10/20/2026 (MT Newswires) -- Alvotech (ALVO.IC, ALVO-SDB.ST) secured the US Food and Drug Administration's approval for a new manufacturing process for Simlandi, or adalimumab-ryvk, a biosimilar to Humira. The biotechnology company said Tuesday it plans to implement the new process, dubbed Process 2.0, at its DSM2 manufacturing facility in Reykjavik, Iceland, more than doubling the output of adalimumab per batch.