Formycon’s Eylea biosimilar wins EC approval

20 January 2025

Germany’s Formycon (ETR: FYB) and its licensing partner Klinge Biopharma have announced that the European Commission (EC) has granted central marketing authorization for FYB203 (aflibercept), a biosimilar to Eylea, under the brand names Ahzantive and Baiama.

This approval encompasses the treatment of age-related neovascular (wet) macular degeneration (nAMD) and other serious retinal diseases such as diabetic macular edema (DME), visual impairment due to myopic choroidal neovascularisation (CNV) and macular edema following retinal vein occlusion (RVO).

The reference product was developed and sold in a collaboration involving Bayer (BAYN: DE) and Regeneron (Nasdaq: REGN), with the former company holding rights in Europe. In 2023, the VEGF inhibitor achieved global sales of approximately $9 billion, highlighting the significance and necessity of a cost-effective alternative like FYB203. Copies have also won approval in the USA, where the original is marketed by Regeneron, said Formycon.

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