Alvotech has received approval from the US Food and Drug Administration (FDA) for a supplement to the Biologics License Application (BLA) for AVT02 (adalimumab-ryvk), marketed in the US as Simlandi. The approval allows drug substances for AVT02 to be manufactured in a second production suite, DSM2, at Alvotech’s Reykjavik facility in Iceland.

The approval further confirms the resolution of inspection-related matters at the Reykjavik site and enables Alvotech to manufacture AVT02 drug substance for US commercial supply in either DSM1 or DSM2. The company said the addition of DSM2 effectively doubles the drug substance manufacturing capacity available for the US market and provides greater flexibility for commercial supply.

DSM2 supports the complete drug substance manufacturing process, including cell culture and purification. The suite is already approved for commercial drug substance manufacturing for European markets, including AVT02, AVT03 and AVT05.

The FDA approval follows the agency’s closure of its latest inspection of the Reykjavik facility in July 2026 with a Voluntary Action Indicated (VAI) classification. Alvotech expects the FDA to be able to take action on other pending applications associated with the facility according to their respective goal dates. These include applications for AVT05, a proposed biosimilar to Simponi and Simponi Aria (golimumab); AVT06, a proposed biosimilar to Eylea (aflibercept); AVT03, a proposed biosimilar to Prolia and Xgeva (denosumab); and AVT16/AVT80, proposed biosimilars to Entyvio (vedolizumab). Each application remains subject to individual FDA review and regulatory decisions.

AVT02 is a monoclonal antibody approved as a biosimilar to Humira (adalimumab) in more than 50 countries, including the US, Europe, Canada and Australia. In the US, it is marketed as Simlandi and under private label, while it is marketed as Hukyndra in Europe, Simlandi in Canada and Adalacip in Australia.

Teva Pharmaceuticals is Alvotech’s strategic partner for the exclusive commercialisation of Simlandi in the US, while Alvotech is responsible for its development and manufacturing. Alvotech, founded by Robert Wessman, focuses on the development and manufacture of biosimilar medicines through an integrated development and manufacturing model.