Global biotechnology company Alvotech (NASDAQ: ALVO; STO: ALVO-SDB), which develops and manufactures biosimilar medicines, said on Monday it has received US Food and Drug Administration approval for a supplement to the Biologics License Application for AVT02 (adalimumab-ryvk).

The decision allows drug substance for the product, marketed in the United States as SIMLANDI, to be manufactured in a second suite at its Reykjavik facility and confirms resolution of earlier inspection-related matters at the site.

The new suite, DSM2, supports the full drug substance process, including cell culture and purification, and doubles Alvotech's capacity for US supply. DSM2 is already approved for commercial drug substance production for European markets, including for AVT02, AVT03 and AVT05.

Following the FDA approval, Alvotech can manufacture AVT02 drug substance for US commercial supply in either DSM1 or DSM2, providing additional capacity and operational flexibility. The approval follows the FDA's July 2026 closure of its most recent inspection of the Reykjavik facility with a Voluntary Action Indicated classification.

AVT02 is a monoclonal antibody approved as a biosimilar to adalimumab in more than 50 countries and is marketed under various names, including SIMLANDI in the United States. Teva Pharmaceuticals is Alvotech's exclusive US commercialisation partner for SIMLANDI, while Alvotech leads development and manufacturing.