Alvotech and its U.S. partner Teva announced a settlement and license agreement with Regeneron Pharmaceuticals that grants a U.S. license entry date for AVT06, the company’s proposed biosimilar to the eye‑disease drug Eylea (aflibercept). The agreement, signed on December 19, 2025, sets a definitive launch window in the fourth quarter of 2026, with the possibility of an earlier entry if the U.S. Food and Drug Administration (FDA) approves the product sooner.
The settlement follows AVT06’s marketing approvals in Japan on September 19, 2025, and in the European Economic Area on August 21, 2025, and it provides a clear regulatory pathway for the U.S. launch. While the agreement secures a license entry date, AVT06 still requires FDA approval before it can be sold in the United States. The “earlier launch” clause applies only if the FDA grants approval ahead of the scheduled Q4 2026 window, a scenario that would accelerate revenue generation for Alvotech and its partner Teva.
Alvotech’s strategy has long focused on expanding its biosimilar portfolio beyond its flagship Humira and Stelara products. The AVT06 milestone is a key step toward capturing a share of the large U.S. ophthalmology market, which is driven by high‑cost treatments for retinal diseases such as age‑related macular degeneration and diabetic macular edema. By securing a U.S. launch pathway, Alvotech positions itself to compete directly with Regeneron’s Eylea, potentially creating price competition in a market that has historically been dominated by a single high‑margin product.
Financially, Alvotech reaffirmed its 2025 guidance, projecting revenues of $570‑$600 million and adjusted EBITDA of $130‑$150 million, while setting 2026 revenue guidance at $650‑$700 million and adjusted EBITDA at $180‑$220 million. The guidance reflects the company’s confidence in the AVT06 launch timeline but also acknowledges potential FDA approval delays. Despite these optimistic forecasts, Alvotech’s financial health remains a concern, with a negative Altman Z‑Score and significant leverage that prompted a recent convertible bond offering to fund research and scale production.
Robert Wessman, Chairman and CEO of Alvotech, said the settlement “positions the company and its partner Teva very well for a successful launch in the U.S. market next year, pending FDA approval.” He added that the agreement “reinforces our commitment to delivering affordable biosimilar alternatives to high‑cost biologics and expands our reach into new therapeutic areas.” The settlement is widely viewed as a strategic win that could broaden Alvotech’s revenue base and strengthen its competitive position in the biosimilar market.
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