On 20 January 2025, Formycon and Klinge Biopharma announced that FYB203/Ahzantive®/Baiama® (aflibercept), biosimilar to Regeneron/Bayer’s Eylea®, has been granted marketing approval by the European Commission. The approval covers all countries in the European Economic Area and indications for nAMD, 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. It was approved in the US in June 2024, where it is subject to a preliminary injunction granted in June 2024, resulting from a patent infringement proceeding brought by Regeneron in November 2023. Formycon lodged an appeal from the preliminary injunction order on 25 June 2024.
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.