FDA approves second U.S.-supply manufacturing suite for Alvotech's SIMLANDI biosimilar

What's the deal? On 5 October 2026 the US Food and Drug Administration approved a supplement to the Biologics License Application for AVT02 (adalimumab-ryvk), marketed in the US as SIMLANDI — Alvotech's biosimilar to Humira (adalimumab). The approval enables the drug substance to be manufactured in a second production suite (DSM2) at the company's Reykjavik facility in Iceland, effectively doubling the drug substance manufacturing capacity available to support US supply. DSM2 covers the complete manufacturing process, including cell culture and purification, and was already approved for commercial supply in European markets, including for AVT02, AVT03 and AVT05.

Why it matters: The decision follows the FDA's July 2026 closure of its inspection of the Reykjavik site with a Voluntary Action Indicated (VAI) classification, and further confirms the resolution of earlier inspection-related matters at the facility. AVT02 is approved as a biosimilar to Humira in more than 50 countries and is marketed in the US as SIMLANDI under an exclusive US commercialisation partnership with TevaDealroom has a profile for this one. Try Dealroom →. Added manufacturing capacity improves supply flexibility for the US market.

Read more: GlobeNewswire, 5 October 2026