Alvotech Approves Second Production Suite for AVT02 Drug Substance

REYKJAVIK, Iceland (October 5, 2026) - Alvotech (NASDAQ: ALVO), a global biotechnology company specializing in the development and manufacture of biosimilar medicines, has secured a significant regulatory milestone with the U.S. Food and Drug Administration (FDA). The FDA has approved a supplement to the Biologics License Application (BLA) for AVT02 (adalimumab-ryvk), enabling the drug substance for the product to be manufactured in a second production suite at the company’s Reykjavik facility. This approval further confirms the resolution of inspection-related matters at the Reykjavik site.

The second suite, DSM2, supports the complete drug substance manufacturing process, including cell culture and purification, and doubles Alvotech’s manufacturing capacity available to support U.S. supply. DSM2 is already approved for the manufacture of commercial drug substance for European markets, including for AVT02, AVT03, and AVT05. Following the FDA approval, Alvotech can now manufacture AVT02 drug substance for U.S. commercial supply in either DSM1 or DSM2, providing additional capacity and greater flexibility across its manufacturing operations.

The approval follows the FDA’s July 2026 closure of its most recent inspection of the Reykjavik facility with a Voluntary Action Indicated (VAI) classification. Alvotech therefore 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 BLAs for AVT05, Alvotech’s proposed biosimilar to Simponi® and Simponi Aria® (golimumab), AVT06, Alvotech’s proposed biosimilar to Eylea® (aflibercept), AVT03, Alvotech’s proposed biosimilar to Prolia® and Xgeva® (denosumab) and AVT16/AVT80, Alvotech’s proposed biosimilars to Entyvio® (vedolizumab). Each application remains subject to the FDA’s individual review and regulatory decision.

AVT02, marketed in the U.S. as SIMLANDI®, is a monoclonal antibody approved as a biosimilar to Humira® (adalimumab) in more than 50 countries globally, including the United States, Europe, Canada, and Australia. Teva Pharmaceuticals is Alvotech’s strategic partner for the exclusive commercialization of SIMLANDI® in the United States, while Alvotech is responsible for development and manufacturing.

The approval underscores Alvotech’s commitment to expanding its manufacturing capabilities to meet the growing demand for biosimilar medicines. With the addition of DSM2, the company aims to enhance its operational flexibility and ensure a steady supply of AVT02 to the U.S. market.