Alvotech (ALVO) and Teva Pharmaceutical Industries Ltd. (TEVA) have secured a U.S. license entry date for AVT06, the proposed biosimilar to Regeneron's Eylea, setting the stage for a potential fourth-quarter 2026 launch, pending FDA approval.
AVT06, an Aflibercept biosimilar, has already cleared regulatory hurdles in the United Kingdom, Japan, and across the European Economic Area.
The settlement with Regeneron grants commercial entry in the U.S. in late 2026 - or earlier under certain circumstances- marking a major milestone for the partners' ophthalmology portfolio expansion.
Robert Wessman, Alvotech's Chairman and CEO, said the agreement positions the companies for a U.S. debut following recent approvals in Europe and Japan, reinforcing momentum behind the biosimilar's global rollout.
In January 2024, Alvotech reported positive results from a confirmatory clinical study comparing AVT06 with Eylea in patients with neovascular wet age-related macular degeneration. The trial met its primary endpoint, demonstrating high similarity in efficacy, safety, and immunogenicity between the biosimilar candidate and the reference product.
Aflibercept, the active ingredient in Eylea, works by binding vascular endothelial growth factors to inhibit receptor activation, neovascularization, and vascular permeability- key drivers of retinal disease progression.
AVT06 is marketed as Mynzepli in the U.K. and European Economic Area and as Aflibercept BS in Japan. Its expanding regulatory footprint underscores Alvotech's strategy to build a diversified biosimilar portfolio spanning autoimmune disorders, eye disease, osteoporosis, respiratory disease, and oncology.
The settlement strengthens Teva's biosimilar ambitions under its "Pivot to Growth" strategy, which emphasizes expanding its innovative and biosimilar pipeline while leveraging its global generics infrastructure.
ALVO has traded between $4.32 and $13.07 over the past year. The stock closed yesterday's trading at $4.73, down 5.04%.
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