On 24 October 2025, IAM reported that the Munich Regional Court has granted Regeneron a permanent cross-border injunction against Formycon preventing launch of FYB203, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept), across 20 countries. The permanent injunction follows a cross-border preliminary injunction granted by the Court in September 2025, based on a finding of infringement by equivalence of Regeneron’s formulation patent, EP 2364691.
FYB203 received European marketing approval in January 2025 as Baiama® and Ahzantive®, and UK approval in February 2025. FYB203 was developed by Formycon, and Klinge holds the exclusive commercialisation rights. In mid-January 2025, Formycon/Klinge and Teva Pharmaceuticals entered a collaboration agreement for the semi-exclusive commercialisation of FYB203 (as Ahzantive®) in Europe (excluding Italy) and Israel. On 17 September 2025, Formycon announced that Klinge had entered a semi-exclusive licence agreement with Horus Pharma, for the commercialisation of FYB203 (under the brand name Baiama®) in selected European countries.
The dispute between Regeneron/Bayer and Formycon in relation to FYB203 is not limited to Germany, with legal proceedings having been conducted in the US, UK, Italy, Belgium, the Netherlands, and France. In the US, FYB203 is set to launch in Q4/2026 following settlement of BPCIA litigation between Formycon and Regeneron in October 2025. Formycon may launch FYB203 in the UK in November 2025, following a February 2025 approval by the MHRA and a failed UK preliminary injunction application by Regeneron in October 2025 (subject to any appeal).