• Formycon and its partners entered into a settlement and license agreement with Regeneron for FYB203/AHZANTIVE® (Aflibercept-mrbb)
  • Pending litigation at the U.S. District Court for the Northern District of West Virginia fully resolved
  • Commercial launch of FDA approved FYB203 in the U.S. expected in Q4/2026 by commercialization partner Valorum Biologics

Planegg-Martinsried, Germany –  Formycon AG (FSE: FYB, “Formycon”), together with its license partner Klinge Biopharma GmbH (“Klinge”) and Valorum Biologics (“Valorum”), announces a settlement and license agreement (“Agreement”) with Regeneron Pharmaceuticals, Inc. (“Regeneron”), resolving all patent disputes related to its FDA-approved Eylea®2 biosimilar for the U.S. market. 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.

“This agreement marks a significant milestone for Formycon and our partners. It resolves all outstanding patent matters and establishes a clear timeline for the U.S. launch of FYB203/AHZANTIVE®. Together with Valorum Biologics, our exclusive commercialization partner, we are committed to ensuring that patients and healthcare providers in the United States gain access to a high-quality, affordable biosimilar option for retinal diseases. This achievement highlights our ability to navigate complex regulatory and legal frameworks and reinforces our dedication to expanding patient access in the U.S. market,” says Nicola Mikulcik, Chief Business Officer of Formycon AG.

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 (RVO). The active ingredient, aflibercept, inhibits vascular endothelial growth factor (VEGF), 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.


1) AHZANTIVE® is a registered trademark of Klinge Biopharma GmbH
2) Eylea® is a registered trademark of Regeneron Pharmaceuticals Inc.