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 marks a significant step toward providing a more affordable treatment option for several serious retinal diseases.
Broad Application for Retinal Diseases
FYB203 has been recommended for approval in Europe for the treatment of adult patients with 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). These conditions represent a significant burden on public health, often leading to severe vision loss if left untreated.
Regulatory Pathway and Market Availability
The positive opinion from the CHMP is a crucial regulatory milestone. The European Commission is expected to grant a central marketing authorization, valid across all European Economic Area (EEA) countries, including the 27 EU Member States, Iceland, Liechtenstein, and Norway, in the second half of January 2025. FYB203 will be marketed under the trade names AHZANTIVE and Baiama in the European Union.
Industry Perspective
Dr. Stefan Glombitza, CEO of Formycon AG, stated, "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 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 received approval from the US Food and Drug Administration (FDA) in June 2024, indicating a consistent positive assessment of its safety and efficacy across different regulatory bodies.
