CHMP positive for FYB 203 a biosimilar candidate to Eylea (aflibercept)
Formycon AG and its licensing partner Klinge Biopharma GmbH (Klinge) jointly announce that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion for the marketing authorization of FYB 203, a biosimilar candidate to Eylea (aflibercept)
Dr. Stefan Glombitza, CEO of Formycon AG, commented: „We are excited about the positive CHMP opinion for FYB 203, our biosimilar candidate to Eylea . As our second ophthalmic biosimilar therapy following the success of our Lucentis biosimilar, FYB 203 represents a further advancement in treatment options for serious retinal diseases. After FDA approval in June, this milestone is a testament to the expertise, dedication and hard work of the entire Formycon team and underscores our commitment to enhancing patient care through affordable alternatives. We are now awaiting European Commission approval in the second half of January 2025 and look forward to offering patients a high-quality treatment option that can improve their quality of life.”
Under the tradenames Ahzantive, Baiama,FYB 203 has been recommended by the CHMP for approval in Europe for treating adult patients with 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).
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