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

Alvotech has received FDA approval to increase its U.S. manufacturing capacity for the Humira biosimilar SIMLANDI, specifically by doubling the drug substance capacity at its Reykjavik site. This approval allows the AVT02 drug substance to be produced in either of the two drug substance suites in Reykjavik. Additionally, it confirms the resolution of previous FDA inspection-related issues at the site.