US FDA Closes Inspection of Alvotech's Manufacturing Facility in Iceland

MT Newswires · 3d ago
10:44 AM EDT, 07/29/2026 (MT Newswires) -- The US Food and Drug Administration closed its inspection of Alvotech's (Z450.F, Z45.F) manufacturing facility in Reykjavik, Iceland, with a classification of voluntary action indicated. Chief Executive Officer Lisa Graver said Wednesday that the biosimilar specialist is confident that the actions it has taken have "effectively" addressed the US FDA's identified observations. The inspection was conducted in May.