FDA Approves Biosimilar FYB203/AHZANTIVE® for Retinal Diseases

The U.S. Food and Drug Administration (FDA) has granted approval for FYB203/AHZANTIVE® (aflibercept-mrbb), a biosimilar to Eylea®. This announcement was made by Formycon AG and its licensing partner Klinge Biopharma GmbH.

FYB203/AHZANTIVE® is approved for treating neovascular Age-Related Macular Degeneration (nAMD), Diabetic Macular Edema (DME), Diabetic Retinopathy (DR), and Macular Edema following Retinal Vein Occlusion (RVO). The decision follows a comprehensive evaluation of data demonstrating the biosimilar's comparable efficacy, safety, pharmacokinetics, and immunogenicity to Eylea®.

The thorough evaluation included analytical, pre-clinical, clinical, and manufacturing data, ensuring that FYB203/AHZANTIVE® meets the necessary standards for patient treatment in these serious retinal conditions.