The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the marketing authorization of FYB203, a biosimilar candidate to aflibercept. This decision marks a significant step toward providing a more affordable treatment option for patients with serious retinal diseases.
FYB203, developed by Formycon AG and Klinge Biopharma GmbH, 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).
Regulatory Milestones and Trade Names
The positive opinion from the CHMP is a crucial regulatory milestone. The European Commission is expected to make its final decision regarding marketing authorization in the second half of January 2025. Once approved, FYB203 will be marketed under the trade names AHZANTIVE and Baiama within the European Union.
Dr. Stefan Glombitza, CEO of Formycon AG, expressed enthusiasm about 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 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, underscoring its potential as a valuable treatment option worldwide.
The CHMP's scientific assessment report will form the basis for the European Commission’s decision to grant a central marketing authorization valid in all European Economic Area (EEA) countries, including the 27 European Union (EU) Member States as well as Iceland, Liechtenstein, and Norway.
