Formycon AG and its licensing partner Klinge Biopharma GmbH jointly announced the FDA approval of FYB203/Ahzantive (aflibercept-mrbb), a biosimilar to Eylea (Regeneron).

FYB203/Ahzantive obtained FDA approval for the treatment of patients with age-related neovascular (wet) macular degeneration (nAMD) and other serious retinal diseases such as diabetic macular edema, diabetic retinopathy and macular edema following retinal vein occlusion, Formycon said in a press release. The active ingredient inhibits the vascular endothelial growth factor, which is responsible for the excessive formation of blood vessels in the retina.

According to Formycon, the FDA approval for FYB203/Ahzantive is based on a thorough evaluation of a comprehensive data package including analytical, pre-clinical, clinical and manufacturing data. FYB203/Ahzantive demonstrated comparable efficacy, safety, pharmacokinetics and immunogenicity to the reference drug Eylea in patients with nAMD.