On 25 February 2025, Formycon and Klinge Pharma announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Ahzantive®/FYB203 (aflibercept), biosimilar to Regeneron/Bayer’s Eylea®. Ahzantive® is approved in the UK for nAMD and other retinal disease including diabetic macular oedema (DME), visual impairment due to myopic choroidal neovascularisation (CNV) and macular oedema following retinal vein occlusion (RVO).
FYB203 received a positive opinion from Europe’s Committee for Medicinal Products for Human Use (CHMP) in November 2024 (under the brand names Ahzantive® and Baiama®) and was granted marketing approval by the European Commission in January 2025.
FYB203 was approved in the US in June 2024, where it is subject to a preliminary injunction granted in June 2024, and upheld at the end of January 2025, resulting from a patent infringement proceeding brought by Regeneron in November 2023.
Formycon developed FYB203 and Klinge holds the exclusive global commercialisation rights. In mid-January 2025, Formycon/Klinge and Teva Pharmaceuticals entered a collaboration agreement for the semi-exclusive commercialisation of FYB203 in Europe (excluding Italy) and Israel.