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

Benzinga · 3d ago

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