Alvotech and Teva Secure U.S. Settlement for Biosimilar Eylea (AVT06), Targeting Q4 2026 Launch

Alvotech (AVTX), in partnership with Teva Pharmaceuticals (TEVA), has secured a definitive U.S. settlement date for the commercial launch of AVT06, its proposed biosimilar referencing Eylea® (aflibercept). According to the settlement agreement, the biosimilar can be marketed in the U.S., provided it receives approval from the U.S. Food and Drug Administration (FDA), starting in the fourth quarter of 2026.

Settlement Clears Path for Biosimilar Aflibercept

The resolution of the patent litigation between Alvotech and the originator company provides a clear timeline for the introduction of AVT06 into the highly lucrative U.S. ophthalmology market. AVT06 is a proposed biosimilar to Eylea, a vascular endothelial growth factor (VEGF) inhibitor developed by Regeneron Pharmaceuticals (REGN), used primarily to treat wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME).

The settlement is a standard mechanism in the pharmaceutical industry, allowing biosimilar developers to finalize their launch strategies and manufacturing scale-up while providing the originator company with a defined period of market exclusivity. For Alvotech and Teva, the agreement solidifies their joint strategy to bring a cost-effective alternative to patients requiring long-term treatment for serious eye conditions.

Key Terms of the Agreement

The core provision of the settlement is the fixed launch window. The ability to market AVT06 in the U.S. is contingent upon two primary factors:

• Successful regulatory approval of AVT06 by the FDA.
• The arrival of the fourth quarter of 2026.

Crucially, the settlement language also includes a provision for an accelerated launch. The proposed biosimilar can be marketed “earlier under certain circumstances,” although the specific conditions that would trigger an earlier market entry were not disclosed in the public announcement. This clause provides Alvotech and Teva with strategic flexibility should market dynamics or further legal developments warrant an accelerated timeline.

Market Impact and Forward Outlook

Eylea (aflibercept) is one of the world’s top-selling biologic drugs, generating billions in annual revenue for Regeneron. The introduction of biosimilar competition is expected to significantly reduce healthcare costs for payers and patients, aligning with Alvotech’s stated mission of broadening the availability of high-quality, cost-effective biosimilars globally.

The Q4 2026 launch date positions AVT06 as a potential early entrant in the U.S. aflibercept biosimilar market. While the FDA approval process remains rigorous, securing the settlement date is a major de-risking event for the partnership, shifting the focus entirely to manufacturing readiness and commercial execution.

The partnership between Alvotech, which focuses on development and manufacturing, and Teva, which handles commercialization and distribution in the U.S., leverages both companies' strengths. This collaborative approach is essential for successfully navigating the complex regulatory and commercial landscape of the U.S. biosimilar market.

The certainty provided by the settlement allows Alvotech to better plan its financial outlook and resource allocation, particularly concerning its research and development pipeline and global product launches. Investors will now monitor the FDA approval process for AVT06 and any subsequent updates regarding the potential for an earlier launch date.