Alvotech announces cGMP surveillance inspection of Reykjavik facility

Alvotech (ALVO) announces that the FDA has completed a routine cGMP surveillance inspection of the company’s manufacturing facility in Reykjavik, Iceland. At the conclusion of the inspection on May 8, the FDA issued a Form 483. The company believes the observations can be addressed quickly and do not raise any substantial issues with the site or its operations. Based on the outcome of the inspection, Alvotech said it is well positioned to resubmit the relevant biologics license applications this quarter, once the final data have been compiled. Alvotech continues to expect FDA approval for the relevant BLAs during 2026.