European biotechnology company Alvotech S.A. (NASDAQ: ALVO) and Teva Pharmaceuticals, a US affiliate of Israeli drugmaker Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), on Friday said they have reached a settlement and licence agreement with Regeneron Pharmaceuticals Inc. (NASDAQ: REGN) covering the US launch of AVT06.

Under the agreement, AVT06, Alvotech's proposed biosimilar to Eylea (aflibercept), may be marketed in the United States in the fourth quarter of 2026, or earlier under certain circumstances, subject to approval by the US Food and Drug Administration.

AVT06 has already been approved for marketing as an aflibercept biosimilar in the United Kingdom, Japan and the 30 countries of the European Economic Area, including all European Union member states as well as Norway, Iceland and Liechtenstein.

In January 2024, Alvotech reported positive top-line results from a confirmatory clinical study in patients with neovascular (wet) age-related macular degeneration, showing high similarity between AVT06 and Eylea in efficacy, safety and immunogenicity.