Reykjavik, Iceland; Tel Aviv, Israel; and Pasipani, New Jersey, December 19, 2025 (Global News Agency) -- Alvotech (ALVO), a biotechnology company focused on the development and manufacture of biosimilars for patients worldwide, and Teva Pharmaceuticals, a U.S. subsidiary of Teva Pharmaceutical Industries, Inc. (TEVA), today announced that they have entered into a settlement and licensing agreement with Regeneron Pharmaceuticals Inc. concerning Alvotech's U.S. launch of the biosimilar AVT06. The settlement agreement sets a licensing entry date for AVT06 in the U.S. for the fourth quarter of 2026, or in some cases earlier.
"Following recent marketing approvals in Europe and Japan, we are pleased to have secured a settlement date in the U.S. for our biosimilar candidate, Eylea, an important biologic for the treatment of retinal diseases. This will lay a strong foundation for Alvotech and our commercial partner Teva to successfully launch in the U.S. market next year (pending FDA approval)," said Robert Wessman, Chairman and CEO of Alvotech.
AVT06 has been approved for marketing as a biosimilar of aflibercept in the UK, Japan, and 30 countries in the European Economic Area, which includes all 27 EU member states, as well as Norway, Iceland, and Liechtenstein.
In January 2024, Alvotech announced a confirmatory clinical study comparing the efficacy, safety, and immunogenicity of AVT06 with Eylea (aflibercept) in patients with neovascular (wet) AMD, with positive results. The study met its primary endpoint, showing that Alvotech's biosimilar candidate is highly similar to Eylea.
About AVT06: AVT06 is a proposed biosimilar similar to Eylea (aflibercept). Aflibercept binds to vascular endothelial growth factor (VEGF) and inhibits VEGF receptor binding and activation, angiogenesis, and vascular permeability [2]. AVT06 has been approved for marketing in the UK and the European Economic Area under the brand name Mynzepli (aflibercept) and in Japan under the name AFLIBERCEPT BS.
