On 13 January 2025, Teva Pharmaceuticals announced that it has entered into a strategic collaboration agreement with Klinge Biopharma and Formycon for the commercialisation of FYB203/Ahzantive®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept), in Europe (excluding Italy) and Israel. FYB203 was developed by Formycon, and Klinge holds the exclusive global commercialisation rights.
FYB203 received a positive opinion from Europe’s Committee for Medicinal Products for Human Use (CHMP) in November 2024 (under the brand names Ahzantive®/Baiama®) for the treatment of nAMD, macular oedema following retinal vein occlusion (RVO), diabetic macular oedema (DME) and myopic choroidal neovascularisation (mCNV). Formycon expects to receive marketing approval later this month.
FYB203 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.
Teva and Formycon/Bioeq previously entered into an exclusive commercialisation agreement in 2021 in relation to FYB201 (ranibizumab), biosimilar to Genentech’s Lucentis®. That agreement covered Canada, Europe and selected other countries.