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 suites

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