Formycon AG and Klinge Biopharma GmbH recently announced that the US Food and Drug Administration has approved Ahzantive (aflibercept-mrbb) as a biosimilar to Regeneron’s Eylea (aflibercept). The new drug can be administered intravitreally for treatment of age-related neovascular (wet) macular degeneration (nAMD) and other serious retinal diseases, including diabetic macular edema, diabetic retinopathy, and macular edema following retinal vein occlusion.

“With Ahzantive and our already approved Lucentis biosimilar FYB201, we have achieved an outstanding position in ophthalmic biosimilar therapies,” Dr. Stefan Glombitza, CEO of Formycon AG, said in a press release. “We are thus improving healthcare for patients with retinal diseases by offering effective, safe and, above all, affordable treatment options.”

Ahzantive is the third Eylea biosimilar to receive FDA approval; two others, Yesafili (aflibercept-jbvf; Biocon Biologics) and Opuviz (aflibercept-yszy; Samsung Bioepis), were approved in May. However, it is unclear when these biosimilars will be available. Regeneron, which reported US net sales of more than $5.72 billion from Eylea in 2023, has filed patent-infringement lawsuits against several biotech companies seeking to make aflibercept biosimilars.

Formycon has also submitted a marketing authorization application for Ahzantive to the European Medicines Agency (EMA) in late 2023, with an anticipated decision by early 2025.