Alvotech and Teva Secure Q4 2026 U.S. Launch Date for Eylea Biosimilar AVT06 Following Regeneron Settlement
Alvotech (ALVO), a global biotech company specializing in biosimilar development, and its commercial partner Teva Pharmaceuticals (TEVA), a U.S. affiliate of Teva Pharmaceutical Industries Ltd., have secured a definitive U.S. license entry date of Q4 2026 for their proposed biosimilar, AVT06. This timeline was established following a settlement and license agreement reached with Regeneron Pharmaceuticals Inc. (REGN), the manufacturer of the reference product, Eylea (aflibercept).
Resolving Patent Disputes for a Blockbuster Drug
The announcement, made on December 19, 2025, confirms the resolution of patent litigation surrounding AVT06, Alvotech's proposed biosimilar to Eylea. The settlement grants Alvotech the right to launch AVT06 in the United States during the fourth quarter of 2026, or potentially earlier under certain undisclosed circumstances.
Eylea (aflibercept) is a critical biologic treatment used primarily for ophthalmic conditions, including wet age-related macular degeneration (AMD) and diabetic macular edema. As a blockbuster drug, Eylea represents a significant revenue stream for Regeneron, making the entry of biosimilar competition a material event for the ophthalmology sector and for investors tracking the competitive landscape.
Biosimilars—biologic medical products highly similar to an already approved reference product—are central to global efforts to reduce healthcare costs. By providing high-quality, cost-effective alternatives to expensive originator biologics, companies like Alvotech aim to broaden patient access to necessary treatments.
The settlement provides crucial clarity regarding the market entry timeline for AVT06, allowing Alvotech and Teva to finalize manufacturing and commercialization strategies for the U.S. market.
Strategic Partnership and Market Access
The collaboration between Alvotech and Teva is strategic, leveraging Alvotech’s expertise in developing and manufacturing complex biosimilars and Teva’s established commercial infrastructure and presence in the U.S. pharmaceutical market. The partnership is designed to ensure a successful launch and distribution of AVT06 once regulatory approval is secured from the U.S. Food and Drug Administration (FDA).
Alvotech, headquartered in Reykjavik, Iceland, focuses exclusively on developing high-quality biosimilar medicines. The company’s pipeline includes several high-profile candidates, such as a high-concentration, low-volume adalimumab biosimilar, underscoring its commitment to addressing major therapeutic areas.
Implications for the Biosimilar Landscape
The fixed launch date of Q4 2026 is a significant milestone for Alvotech, providing investors and the supply chain with a clear timeline for commercialization. Patent settlements are common mechanisms in the pharmaceutical industry, allowing originator companies to maintain exclusivity for a defined period while providing biosimilar developers with a guaranteed, non-litigious path to market entry.
The entry of AVT06 is expected to intensify competition in the aflibercept market, potentially leading to price erosion and increased patient access. This dynamic is consistent with trends observed following the introduction of biosimilars for other major biologics, such as adalimumab and rituximab.
While the settlement secures the license entry date, the commercial launch remains contingent upon final regulatory approval of AVT06 by the FDA. Both Alvotech and Teva will now focus on preparing for the commercial ramp-up necessary to meet anticipated demand in the U.S. market starting in late 2026.
