Alvotech and Teva Secure U.S. Settlement Date for AVT06, a Proposed Biosimilar to Eylea®

Core Viewpoint - Alvotech and Teva Pharmaceuticals have reached a settlement with Regeneron Pharmaceuticals regarding the launch of AVT06, a proposed biosimilar to Eylea, allowing for potential U.S. market entry in Q4 2026, pending FDA approval [1][2]. Group 1: Product Development and Approval - AVT06 has received marketing approval as a biosimilar to aflibercept in the UK, Japan, and 30 countries within the European Economic Area [3]. - A confirmatory clinical study demonstrated that AVT06 met its primary endpoint, showing high similarity in efficacy, safety, and immunogenicity compared to Eylea in patients with neovascular age-related macular degeneration [4]. Group 2: Strategic Partnerships and Market Positioning - The settlement positions Alvotech and Teva favorably for a successful U.S. launch of AVT06, following recent approvals in Europe and Japan [2]. - Alvotech aims to be a global leader in the biosimilar market, with a pipeline that includes eight disclosed biosimilar candidates targeting various diseases [8].