FDA approves Eylea biosimilar FYB203/Ahzantive

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 approved FYB203/Ahzantive as a biosimilar to Eylea, according to a joint press release from Formycon and Klinge Biopharma.

“The FDA approval of FYB203/Ahzantive is another key milestone on our way to becoming the leading pure-play biosimilar developer,” Stefan Glombitza, PhD, CEO of Formycon, said in the release. “With the Eylea biosimilar FYB203/Ahzantive and our already approved Lucentis biosimilar FYB201, we have achieved an outstanding position in ophthalmic biosimilar therapies. We are thus improving health care for patients with retinal diseases by offering effective, safe and, above all, affordable treatment options.”

A decision on a marketing authorization application for FYB203 is expected from the European Medicines Agency by early 2025.

July 5, 2024