Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its license partner Klinge Biopharma GmbH (“Klinge”) announce that the European Medicines Agency (“EMA”) has accepted the marketing authorization application (“MAA”) for FYB203, a biosimilar candidate to Eylea®1 (Active Ingredient: Aflibercept), for review.

Aflibercept is used in the treatment of neovascular age-related macular degeneration (“nAMD”) and other severe retinal diseases. Around 67 million people in Europe are affected by AMD[[i]]. Due to current demographic trends, this number is expected to continue to rise in the coming years. In most cases, intravitreal injections with the VEGF inhibitor Aflibercept can significantly slow down or even stop the loss of vision caused by the neovascular form of AMD.

“The experience of recent years shows that both patients and healthcare systems benefit from biosimilar competition. With the recent EMA acceptance for our ophthalmological biosimilar candidate FYB203, we are an important step closer to providing another effective treatment option – in addition to our already launched biosimilar FYB201 (ranibizumab) – to the many patients affected by severe retinal diseases in Europe”, says Formycon CEO Dr. Stefan Glombitza.


1Eylea® is a registered Trademark of Regeneron Pharmaceuticals Inc.


[i] Prevalence and incidence of age-related macular degeneration in Europe: a systematic review and meta-analysis; Li JQ, Welchowski T, Schmid M, et al. British Journal of Ophthalmology 2020;104:1077-1084.