Recent Updates — ALVO
The U.S. Food and Drug Administration has approved a new manufacturing process for Alvotech’s biosimilar SIMLANDI (adalimumab-ryvk). The approval allows the company to implement Process 2.0 at its DSM2 facility in Reykjavik, Iceland, which more than doubles drug substance output per batch without increasing upstream scale. This enhancement improves manufacturing productivity and frees up capacity to support growing demand across Alvotech’s biosimilars portfolio while maintaining product quality, safety, and efficacy. Alvotech is a biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide.
Alvotech, in partnership with Advanz Pharma, has submitted a European regulatory application for AVT29, a proposed biosimilar to Eylea 8 mg (aflibercept). This marks the first known worldwide regulatory submission for this high-dose formulation. The application is filed as a line extension to Alvotech's existing marketing authorization for Mynzepli, its approved biosimilar to Eylea 2 mg. Advanz Pharma holds exclusive commercialization rights in Europe and will manage registration. Alvotech develops and manufactures biosimilar medicines.
Alvotech and LOTTE Biologics announced a long-term strategic manufacturing partnership to increase global supply of multiple antibody biosimilar products. Under the agreement, LOTTE Biologics will manufacture drug substance at its Syracuse facility in New York, which has 40,000 liters of bioreactor capacity. The collaboration aims to expand Alvotech’s US-based manufacturing footprint and support demand across international markets for the next ten years. Commercial supply is subject to successful technology transfer, manufacturing qualification, and regulatory approvals. Alvotech is a biotechnology company focused on the development and manufacture of biosimilar medicines.
Alvotech announced that the U.S. Food and Drug Administration has accepted for review a Biologics License Application (BLA) for AVT80, a proposed interchangeable biosimilar to Entyvio (vedolizumab) in prefilled syringe and autoinjector formats for subcutaneous administration. This submission complements the BLA for AVT16, an intravenous presentation accepted in May 2026, covering both delivery methods under a partnership with Teva Pharmaceutical Industries Ltd., which handles commercialization. The filing supports Alvotech's broader immunology pipeline aimed at expanding access to biologic medicines for ulcerative colitis and Crohn's disease. Alvotech is a biotechnology company specializing in the development and manufacture of biosimilar medicines.
Alvotech secured an additional term loan facility of $75 million with a maturity date of December 31, 2027, led by GoldenTree Asset Management. Alvotech is a biotechnology company focused on developing and manufacturing biosimilars.
Alvotech closed its previously announced underwritten public offering and the underwriters exercised their option to purchase additional ordinary shares. Alvotech is a biotechnology company focused on development and commercialization of biosimilars.