Alvotech Gets US FDA Nod for Additional Manufacturing Capacity for Humira Biosimilar

05:29 AM EDT, 10/05/2026 (MT Newswires) -- Alvotech (ALVO.IC, ALVO-SDB.ST) received US approval for additional manufacturing capacity for AVT02, or adalimumab-ryvk, a biosimilar to AbbVie's (4AB.F, ABBV.VI) Humira sold in the US as Simlandi. The US Food and Drug Administration approved a supplement to the biologics license application for AVT02, according to a Monday release. The drug is used to treat moderate to severe Crohn's disease, ulcerative colitis, and chronic plaque psoriasis, among other conditions. The approval covers a second production suite, DSM2, at the biotechnology company's facility in Reykjavik, Iceland, which supports the complete drug substance manufacturing process, including cell culture and purification.