On 5 October 2026, Alvotech announced that the FDA has approved its supplement to the Biologics License Application for AVT02 (marketed as Simlandi® in the US), biosimilar to AbbVie’s Humira® (adalimumab). This approval allows drug manufacturing in a second production suite in Alvotech’s Reykjavik facility and will effectively double the manufacturing capacity available to support Alvotech’s biosimilar adalimumab supply in the US.
According to Alvotech, the FDA’s approval “further confirms” resolution of FDA inspection related matters at the Reykjavik site. A July 2025 inspection had found deficiencies at the site, with the FDA then rejecting Alvotech’s golimumab (AVT05), aflibercept (AVT06), and denosumab (AVT03) BLAs in November 2025, December 2025 and January 2026, respectively. After conducting a “remediation project” to address the FDA’s comments, Alvotech resubmitted its BLAs to the FDA in June 2026. In July 2026, the FDA closed its inspection of the Reykjavik site with a Voluntary Action Indicated (VAI) classification (meaning objectionable conditions or practices were found, but the FDA did not take or recommend any administrative or regulatory action).
Alvotech expects the FDA to take action on its pending applications associated with the Reykjavik facility according to their respective goal dates, including for AVT16, biosimilar to Entyvio® (vedolizumab), which is currently the subject of pending BPCIA litigation.