Alvotech Gets FDA Nod For Added US Manufacturing Capacity For Humira Biosimilar SIMLANDI, Doubling Drug Substance Capacity At Reykjavik Site
Approval enables AVT02 drug substance for U.S. commercial supply to be manufactured in either of Alvotech’s two Reykjavik drug substance suitesFurther confirms resolution of FDA inspection-related matters at the
Alvotech got permission to make twice as much of their Humira copy medicine. This shows the FDA is happy with their factory and they can supply more customers.
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