Alvotech and Teva Secure Q4 2026 U.S. Launch Date for AVT06, a Biosimilar to Regeneron's Blockbuster Eylea
Alvotech and Teva Secure U.S. Market Entry for Aflibercept Biosimilar
Alvotech (NASDAQ: ALVO) and its U.S. partner, Teva Pharmaceuticals (NYSE: TEVA), have reached a critical settlement and license agreement with Regeneron Pharmaceuticals Inc. (NASDAQ: REGN) that sets a definitive timeline for the introduction of a key biosimilar in the United States. The agreement grants a license entry date for AVT06, Alvotech's proposed biosimilar to the blockbuster drug Eylea® (aflibercept), in the U.S. market in the fourth quarter of 2026.
The announcement, made on December 19, 2025, resolves potential patent litigation and provides a clear path for the commercialization of AVT06, a drug designed to treat serious retinal conditions, including wet age-related macular degeneration. The settlement also includes a provision allowing for an earlier launch date under certain circumstances, though the specifics of these conditions were not disclosed by the companies.
Significance of the Eylea Biosimilar Market
Eylea (aflibercept) is one of the world's best-selling biologic drugs, generating billions in annual revenue for Regeneron. Its primary use is in ophthalmology, where it is injected into the eye to inhibit vascular endothelial growth factor (VEGF), slowing the progression of vision loss. The entry of biosimilar competition is expected to significantly impact the market dynamics, offering cost savings for healthcare systems and patients.
- Reference Product: Eylea® (aflibercept)
- Biosimilar Candidate: AVT06 (developed by Alvotech)
- U.S. Commercial Partner: Teva Pharmaceuticals
- Definitive Launch Window: Fourth Quarter of 2026
For Alvotech, a global biotech company specializing in biosimilar development and manufacturing, securing a settlement date is a major milestone. Biosimilar development is often fraught with complex patent challenges, and a successful settlement removes significant legal and financial uncertainty, paving the way for future revenue streams through its partnership with Teva.
The settlement grants a license entry date for AVT06 in the United States in the fourth quarter of 2026, or earlier under certain circumstances.
Market Implications and Forward View
The agreement provides investors and healthcare providers with a concrete timeline for the introduction of a lower-cost alternative to Eylea. While the Q4 2026 date is still nearly a year away from the announcement date (December 2025), having a fixed timeline allows Alvotech and Teva to finalize manufacturing scale-up, supply chain logistics, and commercial strategy ahead of the anticipated launch.
For Regeneron, the settlement confirms the timing of competition, allowing the company to prepare its defense strategy, which typically involves maximizing market share retention through contracting and potentially launching an authorized generic or high-dose version of the drug. The 2026 entry date provides a substantial period for Regeneron to continue generating revenue from its proprietary product before facing direct competition from AVT06.
The successful negotiation of this settlement underscores the growing trend in the pharmaceutical industry where originators and biosimilar developers are increasingly opting for negotiated launch dates rather than protracted and costly litigation. This approach benefits the biosimilar developers by guaranteeing a market entry and benefits the originator by maintaining control over the timing of competition.
