Formycon Receives EU Approval for Eylea Biosimilar FYB203 Under the Brand Names Ahzantive and Baiama

Formycon and its licensing partner Klinge Biopharma jointly announce that the European Commission has granted central marketing authorization for FYB203 (aflibercept), a biosimilar to Eylea, under the brand names Ahzantive and Baiama.

The approval encompasses the treatment of wet age-related macular degeneration (AMD), diabetic macular edema (DME), visual impairment due to myopic choroidal neovascularisation (CNV), and macular edema following retinal vein occlusion (RVO). The decision of the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) from November 2024 and applies to all countries in the European Economic Area (EEA), including the 27 member states of the European Union (EU) as well as Iceland, Liechtenstein, and Norway.

In mid-January 2025, Formycon and Teva Pharmaceuticals International signed a licensing agreement for the semi-exclusive commercialization of FYB203 across major parts of Europe and Israel. Concurrently, Formycon has concluded an agreement with Teva for product supply. FYB203 was approved by the FDA in June 2024.