Formycon announced that the FDA has approved Nufymco (ranibizumab-leyk), an interchangeable biosimilar to Lucentis. 

Nufymco was developed by Formycon and is approved in the United States for all indications currently authorized for Lucentis. As an interchangeable biosimilar, Nufymco can be substituted at the pharmacy level in accordance with US regulations.

To support commercialization in the US, Formycon and Bioeq have secured Zydus Lifesciences (including its subsidiaries and affiliates) as an additional partner. Zydus brings expertise in medically administered drugs reimbursed under Medical Part B, a category that includes Nufymco. Zydus recently obtained exclusive rights to commercialize Formycon’s Keytruda biosimilar candidate FYB206 in the United States and Canada.

“Our FDA approval for Nufymco marks an important milestone for Formycon and reaffirms our role as an innovative leader in biosimilar development,” said Dr. Stefan Glombitza, Chief Executive Officer of Formycon AG. “With two 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. This expanded market coverage opens new growth opportunities by enabling a differentiated approach within the complex US healthcare and reimbursement landscape, supporting sustainable market penetration.”

Nufymco is approved for the treatment of patients with wet age-related neovascular macular degeneration (AMD), diabetic macular edema (DME), diabetic retinopathy (DR), macular edema following retinal vein occlusion (RVO), and myopic choroidal neovascularization (mCNV).

Formycon already markets two biosimilars—FYB201/ranibizumab and FYB202/ustekinumab—and has received regulatory approval in the US, Europe and the UK for FYB203/aflibercept. Several additional biosimilar candidates, including FYB208/dupilumab, are currently in development.