Alvotech (NASDAQ:ALVO) has resolved all remaining patent litigation surrounding its biosimilar candidate for the blockbuster eye drug Eylea (aflibercept), reaching a comprehensive global licensing agreement with Regeneron Pharmaceuticals and Bayer AG.
The settlement grants the Reykjavik-based biotech worldwide rights to manufacture and supply its biosimilar, AVT06, to commercial partners, effectively ending years of legal disputes over the multi-billion-dollar retinal treatment.
The agreement outlines a carefully staged entry into major international markets.
Under the terms, Alvotech and its partners are permitted to market the biosimilar in the United Kingdom and Canada beginning immediately.
In Japan, a limited launch for specific indications is scheduled for May 1, 2026, followed by a full-market entry on November 1.
For the European Economic Area and other global territories—excluding the United States—market entry is set for May 1, 2026.
This global deal follows a separate December settlement regarding the lucrative U.S. market.
In that region, Alvotech and its commercial partner Teva Pharmaceuticals are permitted to launch AVT06 in the fourth quarter of 2026, pending FDA approval.
While the financial specifics of the worldwide agreement remain confidential, the deal provides Alvotech with a clear path to compete in a market where Eylea generated nearly $6 billion in sales through the first nine months of 2025.