Alvotech and Teva Reach U.S. Settlement for AVT06
Alvotech and Teva have announced a settlement agreement regarding the marketing of AVT06, a proposed biosimilar to Eylea® (aflibercept), in the United States. The agreement sets a date for potential market entry in the fourth quarter of 2026, contingent on regulatory approval by the U.S. Food and Drug Administration (FDA).
Details of the Settlement Agreement
The settlement allows Alvotech and Teva to market AVT06 in the U.S. starting in late 2026. The agreement also includes provisions for an earlier launch under certain circumstances, although specific details on these conditions have not been disclosed. This settlement resolves patent disputes related to the biosimilar product.
About AVT06 and Eylea®
AVT06 is a biosimilar candidate to Eylea®, a widely used treatment containing aflibercept for various retinal diseases. Biosimilars are biologic medical products highly similar to already approved reference products, offering potential cost savings and increased access for patients.
Regulatory Path Forward
Marketing of AVT06 in the U.S. remains subject to FDA approval. The companies will continue to pursue regulatory review and clearance to bring the biosimilar to market as soon as possible within the agreed timeframe.
Industry Impact
The settlement and planned launch of AVT06 represent a significant step in expanding treatment options for patients requiring aflibercept therapy. The introduction of biosimilars like AVT06 is expected to enhance competition and potentially reduce costs in the biologics market.
