AlvotechFDA closed inspection with VAI classification, removing regulatory overhang and supporting BLA resubmissions.

Alvotech announced that the U.S. FDA has successfully closed its inspection of the company's manufacturing facility in Reykjavik, Iceland, conducted in May 2026. The FDA classified the site as Voluntary Action Indicated, signaling that any observations identified during the inspection have been adequately addressed. CEO Lisa Graver said the closure reflects the company's ongoing commitment to strengthening its quality systems and manufacturing operations, adding that Alvotech continues to work with the FDA to advance recent Biologics License Applications toward approval. The company recently resubmitted BLAs for AVT05, a biosimilar to Simponi, and AVT06, a biosimilar to Eylea, and the FDA accepted the submission of AVT16, a proposed biosimilar to Entyvio, in June 2026. Alvotech has five biosimilars already approved and marketed globally, with a pipeline of 13 disclosed candidates. The stock is currently trading at $3.53, up 13.87 percent.
AlvotechFDA closed inspection with VAI classification, removing regulatory overhang and supporting BLA resubmissions.