The FDA approved FYB203/Ahzantive as a biosimilar to Eylea, according to a joint press release from Formycon and Klinge Biopharma.
FYB203/Ahzantive (aflibercept-mrbb) was approved for the treatment of neovascular age-related macular degeneration, diabetic macular edema, diabetic retinopathy and macular edema following retinal vein occlusion. The decision was based on data that demonstrated comparable efficacy, safety, pharmacokinetics and immunogenicity to Eylea (aflibercept, Regeneron) in patients with neovascular AMD.
“The FDA approval of FYB203/Ahzantive is another key milestone on our