Alvotech And Teva Secure U.S. Settlement Date For AVT06, Proposed Biosimilar To Eylea®, Targeting Q4 2026 Launch

Alvotech, a global biotech company focused on the development and manufacture of biosimilar medicines, and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd., announced that they have reached a settlement and license agreement with Regeneron Pharmaceuticals Inc. regarding the U.S. launch of AVT06, Alvotech’s proposed biosimilar to Eylea® (aflibercept). Under the agreement, AVT06 is scheduled to enter the U.S. market in the fourth quarter of 2026, with the possibility of an earlier launch under certain circumstances.

Robert Wessman, Chairman and CEO of Alvotech, stated that securing a U.S. settlement date for AVT06 is an important milestone following recent marketing approvals in Europe and Japan. He noted that the agreement positions Alvotech and Teva well for a successful launch in the U.S. market next year, pending FDA approval.

AVT06 has already been approved for marketing as an aflibercept biosimilar in the United Kingdom, Japan, and across the 30 countries of the European Economic Area, including all 27 European Union member states as well as Norway, Iceland, and Liechtenstein.

In January 2024, Alvotech announced positive top-line results from a confirmatory clinical study comparing AVT06 to Eylea® in patients with neovascular (wet) age-related macular degeneration (AMD). The study met its primary endpoint, demonstrating high similarity between Alvotech’s biosimilar candidate and Eylea® in terms of efficacy, safety, and immunogenicity.