The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending marketing authorization for FYB203, a biosimilar candidate to aflibercept. This decision paves the way for a more affordable treatment option for several serious retinal diseases affecting adult patients.
FYB203, developed by Formycon AG and Klinge Biopharma GmbH, is recommended for treating conditions including neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), visual impairment due to myopic choroidal neovascularization (CNV), and macular edema following retinal vein occlusion (RVO).
Regulatory Pathway and Market Availability
The positive CHMP opinion is a crucial step towards securing approval in Europe. The European Commission is expected to make its final decision in the second half of January 2025. Once approved, FYB203 will be marketed under the trade names AHZANTIVE and Baiama within the European Union and other European Economic Area (EEA) countries, including Iceland, Liechtenstein, and Norway.
Dr. Stefan Glombitza, CEO of Formycon AG, expressed his enthusiasm for the CHMP opinion, stating, "We are excited about the positive CHMP opinion for FYB203, our biosimilar candidate to Eylea. As our second ophthalmic biosimilar therapy following the success of our Lucentis [ranibizumab] biosimilar, FYB203 represents a further advancement in treatment options for serious retinal diseases... 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."
Prior FDA Approval
FYB203 was previously approved by the US Food and Drug Administration (FDA) in June 2024, indicating its potential global impact in addressing unmet needs in retinal disease management.
