Formycon secures settlement and license agreement with Regeneron

Germany’s Formycon (FSE: FYB) saw its shares rise 10% to 25.25 euros by early afternoon, after its and partner Klinge Biopharma announced a settlement and license agreement with the USA’s Regeneron (Nasdaq: REGN).

The accord resolves all patent disputes related to its Food and Drug Administration (FDA)-approved Eylea (aflibercept) biosimilar for the US market. Under the terms of the agreement, licensee Valorum can launch Ahzantive in the USA 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 US market,” says Nicola Mikulcik, chief business officer of Formycon AG.