Alvotech's Iceland Facility Receives VAI Classification from FDA

Alvotech announced that the U.S. Food and Drug Administration (FDA) has closed its inspection of the company's manufacturing facility in Reykjavik, Iceland, conducted in May 2026. The FDA confirmed the inspection classification as Voluntary Action Indicated (VAI), signifying a positive outcome for the company. Alvotech also highlighted the resubmission of BLAs for AVT05 and AVT06, and the FDA's acceptance of the BLA for AVT16, demonstrating continued progress in its biosimilar pipeline.