Eylea Biosimilar Deal Signals New Era for Retinal Disease Care

REYKJAVIK, Iceland & TEL AVIV, Israel – December 19, 2025 – A landmark settlement is set to reshape the multi-billion-dollar market for retinal disease treatments, promising increased competition and potential cost savings for a critical class of medications. Alvotech and its commercial partner Teva Pharmaceuticals announced today they have reached an agreement with Regeneron Pharmaceuticals, clearing a path for the U.S. launch of AVT06, a biosimilar version of the blockbuster eye drug Eylea® (aflibercept).

Under the terms of the settlement and license agreement, the proposed biosimilar can be marketed in the United States starting in the fourth quarter of 2026, pending final approval from the Food and Drug Administration (FDA). The deal, which allows for an earlier launch under certain circumstances, marks a pivotal moment in the lifecycle of one of the world's most successful biologic drugs and signals a new chapter of competition in ophthalmology.

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

The Shifting Landscape of a Blockbuster Market

The financial stakes surrounding Eylea are immense. The drug, used to treat serious, vision-threatening conditions like wet age-related macular degeneration (AMD) and diabetic macular edema (DME), has been a cornerstone of Regeneron's portfolio. In 2024 alone, the Eylea franchise generated approximately $9.5 billion in global sales, with U.S. revenues accounting for nearly $6 billion. This market dominance has made it a prime target for biosimilar developers eager to capture a share of the lucrative space.

However, the market is already in flux. Regeneron has faced mounting pressure from Roche’s competing drug, Vabysmo, which has been steadily gaining market share since its 2022 approval. Furthermore, Regeneron has been actively transitioning patients to its own next-generation product, Eylea HD, a higher-dose version approved in August 2023 that allows for less frequent injections. This strategic shift has already impacted sales of the original 2 mg Eylea, which saw a 39% drop in U.S. sales in the first quarter of 2025. The impending arrival of biosimilars is set to intensify this competitive pressure, forcing a significant recalculation for patients, payers, and manufacturers alike.

A Crowded Field of Contenders

Alvotech and Teva are not entering an empty arena. The race to bring an aflibercept biosimilar to the U.S. market is highly competitive, with several major pharmaceutical players making significant headway. In May 2024, the FDA approved OPTEYAS™ (aflibercept-aibp), a biosimilar from Samsung Bioepis and Biogen, marking the first official biosimilar competitor to Eylea in the country. It is available in both vial and pre-filled syringe presentations, setting an early competitive benchmark.

Other companies are close behind. Sandoz announced in May 2024 that the FDA had accepted its application for an Eylea biosimilar for review. Meanwhile, companies like Biocon Biologics and Formycon have also demonstrated positive clinical results and are navigating the complex web of patent litigation and regulatory submissions. The settlement between Alvotech/Teva and Regeneron provides crucial certainty, bypassing potentially lengthy and costly patent disputes and setting a firm target for their U.S. commercial strategy.

AVT06 already boasts a strong global regulatory track record, having secured marketing authorization in Japan, the United Kingdom, and across the 30-country European Economic Area, where it is marketed as Mynzepli®. This international validation, coupled with positive clinical trial data announced in January 2024 demonstrating high similarity to Eylea, provides a solid foundation for its forthcoming FDA review.

Regeneron's Defensive Playbook

Facing the inevitable erosion of its exclusivity, Regeneron has executed a robust defensive strategy centered on innovation and life-cycle management. The company's primary defense is Eylea HD, which has seen impressive uptake with $1.2 billion in U.S. sales in 2024. By offering a superior dosing regimen, Regeneron aims to convert a significant portion of the market to its new, patent-protected product before biosimilars of the original formula can gain a foothold. The company has reported that 80% of the market now has reimbursement in place for Eylea HD, a critical factor for its continued adoption.

Historically, Regeneron has also relied on aggressive patent defense to delay competition, making the settlement with Alvotech and Teva particularly significant. Such agreements are becoming a common feature of the biosimilar landscape, providing a predictable pathway to market for biosimilar developers while giving the originator company a controlled, staggered entry of competitors. This allows Regeneron to manage the decline of its legacy product's revenue stream more effectively while focusing on the growth of Eylea HD.

The Promise of Access and Affordability

Beyond the corporate strategies and market share battles, the introduction of aflibercept biosimilars carries a profound implication for patients. The high cost of biologic drugs like Eylea can be a significant barrier to care, placing a heavy financial burden on both healthcare systems and individuals requiring long-term treatment to preserve their vision.

Biosimilars are introduced at a discount to the originator product, fostering competition that historically drives down prices across the board. The emergence of multiple Eylea biosimilars, including AVT06, is expected to generate substantial cost savings for Medicare, private insurers, and patients. These savings can, in turn, expand access to treatment, allowing more people with debilitating retinal diseases to receive the care they need to prevent irreversible vision loss.

As the U.S. market prepares for the arrival of AVT06 in 2026, all eyes will be on the evolving competitive dynamics. The interplay between Regeneron's Eylea HD, Roche's Vabysmo, and a growing slate of biosimilars will redefine the standard of care and cost structure for treating retinal diseases, ultimately shaping the future of vision care for millions of Americans.