Alvotech (NASDAQ:ALVO) and Teva (NYSE:TEVA) have secured a U.S. market entry date for their proposed biosimilar to Eylea® (aflibercept), AVT06, under a settlement agreement with Regeneron.
The biosimilar is set to launch in the U.S. in the fourth quarter of 2026, or potentially earlier under specified circumstances, subject to FDA approval.
AVT06 has already received marketing approvals in the United Kingdom, Japan, and the 30 European Economic Area (EEA) countries, showcasing its broad global acceptance.
A confirmatory study conducted in January 2024 met its primary endpoint, demonstrating high similarity to Eylea® for the treatment of neovascular age-related macular degeneration (AMD), further solidifying AVT06 as a promising alternative.
The agreement with Regeneron resolves ongoing patent disputes, allowing the biosimilar to enter the U.S. market, offering a more affordable treatment option for patients battling neovascular AMD.