Alvotech and Teva reach US settlement date for biosimilar to Eylea

Iceland-based biosimilars developer Alvotech (Nasdaq: ALVO) and a US affiliate of Israel’s Teva Pharmaceutical Industries (NYSE and TASE: TEVA), today announced that they have reached a settlement and license agreement with Regeneron Pharmaceuticals (Nasdaq: REGN) concerning the launch of AVT06, Alvotech’s proposed biosimilar to Eylea (aflibercept) in the USA.

The settlement grants a license entry date for AVT06 in the USA in the fourth quarter of 2026, or earlier under certain circumstances. The US Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) for AVT06 for review in February this year.

“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 US market next year, pending FDA approval,” said Robert Wessman, chairman and chief executive of Alvotech.