Alvotech and Teva Pharmaceuticals announced that they have reached a settlement and license agreement with Regeneron Pharmaceuticals Inc. 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. 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 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.
In January 2024, Alvotech announced positive top-line results from a confirmatory clinical study comparing the efficacy, safety, and immunogenicity of AVT06 to Eylea® (aflibercept) in patients with neovascular (wet) AMD. The study met its primary endpoint, with results demonstrating high similarity between Alvotech’s biosimilar candidate and Eylea®
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