BERLIN (dpa-AFX) - Formycon AG (FYB.DE), in collaboration with its license partners Klinge Biopharma GmbH and Valorum Biologics, has reached a settlement and entered into a license agreement with Regeneron Pharmaceuticals Inc. (REGN). The agreement resolves all outstanding patent disputes concerning Formycon's FDA-approved biosimilar to Eylea for the U.S. market, Formycon said in a statement.
Under the terms of the agreement, Valorum may launch AHZANTIVE in the United States in the fourth quarter of 2026, or potentially earlier under certain circumstances.
Regeneron initiated patent infringement proceedings against Formycon in connection with AHZANTIVE pursuant to the Biologics Price Competition and Innovation Act (BPCIA) in the US Federal District Court for the Northern District of West Virginia in November 2023. This included infringement claims under about 40 patents protecting the reference product Eylea and expiring as late as 2040. All pending litigation has now been resolved by the parties in the agreement.
FYB203/AHZANTIVE received FDA approval in July 2024 for the treatment of patients with neovascular (wet) age-related macular degeneration (nAMD) and other serious retinal diseases, including diabetic macular edema (DME), diabetic retinopathy (DR), and macular edema following retinal vein occlusion. The active ingredient, aflibercept, inhibits vascular endothelial growth factor, targeting abnormal blood vessel formation in the retina.
In June 2025, Formycon announced an exclusive license agreement between Klinge and U.S. biosimilars specialist Valorum for the commercialization of FYB203/AHZANTIVE in the United States and Canada.
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