On July 1, Formycon AG announced the FDA approval of the third aflibercept biosimilar; the new drug will be called Ahzantive® (aflibercept-mrbb). Two biosimilars were approved in late May, and the market for Eylea® biosimilars may get even more crowded: Amgen and Celltrion are awaiting FDA decisions in 2024 on their own biosimilar candidates.
Formycon now has received approvals for two VEG-F inhibitors for the treatment of macular degeneration and other retinal disorders. The German company partnered with Coherus Biosciences and secured approval for its ranibizumab biosimilar Cimerli® in 2022. Coherus sold the commercialization rights to this product to Sandoz in 2024.
In Formycon’s press release, CEO Stefan Glombitza commented, “The FDA approval of Ahzantive is another key milestone on our way to becoming the leading pure-play biosimilar developer. It highlights the expertise and experience of our team. With the Eylea biosimilar Ahzantive and our already approved Lucentis® biosimilar [Cimerli], we have achieved an outstanding position in ophthalmic biosimilar therapies. We are thus improving healthcare for patients with retinal diseases by offering effective, safe and, above all, affordable treatment options.”
Details on the launch of this agent as well as its competitors have not been disclosed. The reference product manufacturer, Regeneron, has sought to delay commercialization through litigation around a single patent.
