On 29 July 2026, Alvotech announced that the US FDA has closed its inspection of Alvotech’s manufacturing facility in Reykjavik, Iceland with the inspection classification “Voluntary Action Indicated (VAI)”. The routine cGMP surveillance inspection was conducted in May 2026.
The VAI classification means objectionable conditions or practices were found during the inspection, however the FDA did not take or recommend any administrative or regulatory action. Alvotech’s CEO, Lisa Graver, stated that “the actions we have taken have effectively addressed the observations identified”.
Alvotech resubmitted its BLAs for AVT05 (golimumab) and AVT06 (aflibercept) to the FDA in June 2026. This followed the receipt of Complete Response Letters from the FDA for Alvotech’s golimumab, aflibercept, and denosumab (AVT03) BLAs in November 2025, December 2025 and January 2026, respectively, and a subsequent “remediation project” undertaken by Alvotech to address the FDA’s comments.