Alvotech and Teva Pharmaceuticals have reached a settlement and license agreement with Regeneron Pharmaceuticals, clearing a key legal hurdle for the US launch of AVT06, Alvotech’s proposed biosimilar to Eylea (aflibercept).

 

Under the agreement, AVT06 is licensed to enter the US market in the fourth quarter of 2026, with the possibility of an earlier launch under certain conditions. The deal positions Alvotech and its commercial partner, Teva, to compete in one of the largest ophthalmology biologics markets, pending approval from the U.S. Food and Drug Administration.

 

“Following recent marketing approvals in both Europe and Japan, we are delighted to secure a US settlement date for our biosimilar candidate to Eylea, an important biologic for the treatment of retinal diseases. This positions Alvotech and our commercial partner Teva very well for a successful launch in the U.S. market next year, pending FDA approval,” said Robert Wessman, Chairman and CEO of Alvotech.

 

AVT06 has already gained marketing approval in the United Kingdom, Japan, and across all 30 countries of the European Economic Area, including the 27 European Union member states as well as Norway, Iceland, and Liechtenstein.