Bioeq, a joint venture between biosimilars developer Formycon AG and Polpharma Biologics Group, announced US Food and Drug Administration (FDA) approval of its biologics license application for Nufymco (ranibizumab-leyk), a biosimilar of Lucentis (ranibizumab; Genentech).

Nufymco is FDA approved for treatment of patients with wet macular degeneration (wAMD), diabetic macular edema (DME), diabetic retinopathy (DR), macular edema due to retinal vein occlusion (RVO), and myopic choroidal neovascularization (mCNV). The drug will be marketed in the United States by Zydus Lifesciences Limited, which previously obtained exclusive rights to Formycon’s Keytruda biosimilar FYB206 in the US and Canada.

“Our FDA approval for Nufymco marks an important milestone for Formycon and reaffirms our role as an innovative leader in biosimilar development,” Dr. Stefan Glombitza, CEO of Formycon AG, said in a press statement. “With 2 strong and internationally established partners, we are ideally positioned to expand access to high-quality and affordable ranibizumab biosimilars for ophthalmic patients in the US.”