On 25 September 2025, the Munich Regional Court granted Regeneron and Bayer a cross-border preliminary injunction (PI) preventing Formycon from launching FYB203, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept). According to the Juve Patent report, the PI covers 22 European countries, including Germany and is based on a finding of infringement by equivalence of Regeneron’s formulation patent, EP 2 364 691. The judgment is not yet available in English.
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 in the US, UK, Italy, Belgium, the Netherlands, and France. In the US, FYB203 is subject to a preliminary injunction granted in June 2024, resulting from a patent infringement proceeding brought by Regeneron in November 2023, which was upheld on appeal in January 2025. In the UK, a hearing in the infringement action brought by Regeneron and Bayer against Formycon and Klinge’s FYB203 took place in the High Court (Patents Court) in June 2025. The UK Court decision is pending.