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- According to the settlement agreement, the proposed biosimilar to Eylea® (aflibercept) can be marketed in the U.S., if approved by the FDA, in the fourth quarter of 2026, or earlier under certain circumstances
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REYKJAVIK, Iceland and TEL AVIV, Israel, Dec. 19, 2025 (GLOBE NEWSWIRE) — Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today 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.
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“Following recent marketing approvals in both Japan and Europe, 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.
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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.
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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® [1].
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About AVT06
AVT06 is a proposed biosimilar to Eylea® (aflibercept). Aflibercept binds vascular endothelial growth factors (VEGF), inhibiting the binding and activation of VEGF receptors, neovascularization, and vascular permeability [2]. AVT06 has been approved under the brand name Mynzepli® (aflibercept) for marketing in the European Economic Area and under the name AFLIBERCEPT BS for marketing in Japan.
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Sources
[1] Agostini, H. et.al. (2025). A randomized, double-masked parallel-group, multicenter clinical study evaluating the efficacy and safety of the biosimilar candidate AVT06 compared to the reference product aflibercept in participants with neovascular age-related macular degeneration. Expert Opinion on Biological Therapy, 1–15. https://doi.org/10.1080/14712598.2025.2519531
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[2] Eylea® product label, accessed on December 18, 2025, https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125387s087lbl.pdf
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Use of trademarks
Eylea® is a registered trademark of Regeneron Pharmaceuticals Inc.
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About Alvotech
Alvotech is a biotechnolgy company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high quality, cost-effective products, and services, enabled by a fully integrated approach and broad in-house capabilities. Alvotech’s current pipeline includes eight disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disease, osteoporosis, respiratory disease, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. For more information, please visit www.alvotech.com. None of the information on the Alvotech website shall be deemed part of this press release.
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