Alvotech & Teva Secure 2026 Launch for Eylea Biosimilar

NEW YORK, NY – December 19, 2025 – Alvotech and its commercial partner Teva Pharmaceuticals have cleared a major legal hurdle in their quest to enter the multi-billion-dollar U.S. market for ophthalmic drugs. The companies announced a settlement and license agreement with Regeneron Pharmaceuticals that sets a U.S. launch date for AVT06, their proposed biosimilar to the blockbuster eye medication Eylea® (aflibercept), for the fourth quarter of 2026, contingent upon final FDA approval.

The agreement positions AVT06 to be one of the first aflibercept biosimilars to challenge Regeneron's market dominance, promising to intensify competition and potentially drive significant cost savings for patients and healthcare systems. Eylea is a critical treatment for several vision-threatening retinal conditions, including neovascular (wet) age-related macular degeneration (AMD) and diabetic macular edema (DME).

“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,” said Robert Wessman, Chairman and CEO of Alvotech, in the company's press release. “This positions Alvotech and our commercial partner Teva very well for a successful launch in the U.S. market next year, pending FDA approval.”

A Shifting High-Stakes Market

The market for Eylea is colossal, representing a significant portion of the anti-vascular endothelial growth factor (anti-VEGF) therapeutics space. The global Eylea market was valued at approximately $9.38 billion in 2023 and is projected to exceed $10.5 billion in 2025. Regeneron's U.S. revenue for its Eylea franchise alone totaled nearly $5.97 billion in 2024.

However, the landscape is rapidly changing. Regeneron has seen sales of its standard-dose Eylea come under significant pressure. In the first quarter of 2025, the company's Eylea franchise sales fell 26% compared to the prior year, with standard Eylea sales in the U.S. plummeting 39% to $736 million. This decline continued through the second and third quarters of 2025, attributed not only to the looming threat of biosimilars but also to strong competition from Roche’s innovative drug Vabysmo and patient affordability constraints driving shifts to lower-cost alternatives.

This market erosion underscores the vulnerability of blockbuster biologics as their patents expire and a wave of biosimilar competitors prepares to enter. The entire anti-VEGF market is projected to contract from an estimated $14.5 billion in 2024 to $12.9 billion by 2030, a decline driven almost entirely by the anticipated price reductions from biosimilar competition.

Regeneron’s High-Dose Defense

In response to this existential threat, Regeneron has executed a formidable defensive strategy centered on its next-generation product, Eylea HD (aflibercept 8 mg). Approved by the FDA in August 2023, Eylea HD’s primary advantage is a less frequent dosing schedule, allowing for injections up to every 16 weeks for certain conditions, compared to the 4-to-8-week interval for standard Eylea. This extended duration offers a significant quality-of-life improvement for patients and a powerful selling point for physicians.

The strategy appears to be working. While standard Eylea sales have faltered, Eylea HD has seen robust growth, with U.S. net sales climbing to $431 million in the third quarter of 2025. Regeneron is aggressively working to convert patients to the high-dose version before biosimilars for the standard dose arrive, effectively aiming to make the original product obsolete. The company is seeking to further bolster Eylea HD with planned enhancements, including a pre-filled syringe expected by mid-2025 and ongoing studies to potentially extend dosing intervals to every 24 weeks.

A Crowded Field of Challengers

Alvotech and Teva are not entering an empty arena. The FDA has already opened the floodgates for Eylea biosimilars, approving six competitors by the end of 2024. The list includes Opuviz from Samsung Bioepis and Yesafili from Biocon Biologics, both of which have been designated as interchangeable biosimilars. This designation allows pharmacists to substitute them for Eylea without a new prescription, a significant commercial advantage.

Other approved, non-interchangeable biosimilars include Celltrion’s Ophthaldia, Amgen’s Ahzantive, and Formycon’s Fycomz. However, a key differentiator is the launch timeline. Through patent settlements with Regeneron, most of these competitors have agreed to U.S. launch dates in 2027 and 2028. Alvotech and Teva’s Q4 2026 entry date, therefore, gives AVT06 a crucial head start over many of its biosimilar rivals, positioning it as an early challenger in the race for market share.

A Vision for Affordability and Access

The most profound impact of this new competitive era will be on the cost of care. The introduction of multiple aflibercept biosimilars is expected to generate billions of dollars in savings for the U.S. healthcare system. Biosimilars typically enter the market at discounts of 15% to 30% or more, and increased competition drives prices down further over time. Projections estimate that aflibercept biosimilars could save the U.S. healthcare system as much as $5.3 billion over five years.

These savings will directly benefit patients through lower out-of-pocket costs and help alleviate the financial burden on payers like Medicare and private insurance companies. For patients with chronic conditions like wet AMD, who require ongoing treatment to preserve their vision, more affordable options can dramatically improve treatment adherence and long-term outcomes.

Alvotech’s AVT06 has already built a strong foundation for physician confidence. The biosimilar has secured marketing approval in the United Kingdom, the European Economic Area, and Japan. Furthermore, a January 2024 confirmatory study demonstrated its high similarity to Eylea in terms of efficacy, safety, and immunogenicity. While the convenience of Eylea HD will be a formidable competitive factor, the substantial cost advantage of AVT06 will be a powerful driver for its adoption by providers and payers. The final hurdle remains FDA approval, as noted in the settlement announcement. Alvotech’s Biologics License Application (BLA) for AVT06 was accepted for Priority Review in July 2024, but the final regulatory green light is still pending before its 2026 launch can be realized.