Alvotech (ALVO) and Teva Pharmaceuticals (TEVA) have reached a settlement and license agreement with Regeneron Pharmaceuticals (REGN) concerning the launch of AVT06, Alvotech’s proposed biosimilar to Eylea (aflibercept) in the United States.
The settlement grants a license entry date for AVT06 in the United States in the fourth quarter of 2026, or earlier under certain circumstances.
“Following recent marketing approvals in both Europe and Japan, we are delighted to secure a U.S. settlement date for our biosimilar candidate to Eylea, an important biologic for the treatment of retinal diseases,” said Robert Wessman, Chairman and CEO of Alvotech (ALVO).
“This positions Alvotech and our commercial partner Teva very well for a successful launch in the U.S. market next year, pending FDA approval,”
AVT06 has been approved for marketing as an aflibercept biosimilar in the United Kingdom, Japan, and the 30 countries of the European Economic Area, which includes all 27 member states of the European Union in addition to Norway, Iceland, and Liechtenstein.
Regeneron Pharmaceuticals (REGN) was down 2.5% premarket, while Alvotech (ALVO) rose 1.7%.
Source: Press Release