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Alvotech announced that the U.S. Food and Drug Administration closed its May 2026 inspection of the Reykjavik…
ALVOWAlvotech
Alvotech announced that the U.S. Food and Drug Administration closed its May 2026 inspection of the Reykjavik manufacturing facility with a Voluntary Action Indicated (VAI) classification. CEO Lisa Graver stated this milestone reflects strengthened quality systems and addresses prior observations, supporting ongoing regulatory efforts for Biologics Licence Applications. The company also highlighted recent pipeline updates, including BLA resubmissions for biosimilars AVT05 (golimumab) and AVT06 (aflibercept), and FDA acceptance of a BLA for AVT16 (vedolizumab). Alvotech is a biotechnology company specializing in the development and manufacture of biosimilar medicines.