FDA Approves Lucentis Biosimilar Nufymco
Ranibizumab-leyk (Nufymco) is approved for all Lucentis indications.
By
Conexiant News Staff
January 2, 2026
Clinical Scorecard: FDA Approves Lucentis Biosimilar Nufymco
At a Glance
Category Detail
Condition Wet Macular Degeneration, Diabetic Macular Edema, Diabetic Retinopathy, Macular Edema due to Retinal Vein Occlusion, Myopic Choroidal Neovascularization
Key Mechanisms Biosimilar to ranibizumab, targeting vascular endothelial growth factor (VEGF)
Target Population Patients with wAMD, DME, DR, RVO, and mCNV
Care Setting Ophthalmology
Key Highlights
Nufymco is a biosimilar of Lucentis (ranibizumab) FDA approved for multiple ophthalmic conditions Marketed in the US by Zydus Lifesciences Limited Developed by Bioeq, a joint venture of Formycon AG and Polpharma Biologics Group Aims to expand access to affordable treatment options
Guideline-Based Recommendations
Diagnosis
Evaluate patients for wAMD, DME, DR, RVO, and mCNV
Management
Consider Nufymco as a treatment option for approved conditions
Monitoring & Follow-up
Regular follow-up for treatment efficacy and adverse effects
Risks
Potential for adverse reactions similar to those of ranibizumab
Patient & Prescribing Data
Patients diagnosed with wet macular degeneration, diabetic macular edema, diabetic retinopathy, macular edema due to retinal vein occlusion, or myopic choroidal neovascularization
Nufymco provides a biosimilar option to improve access to treatment
Clinical Best Practices
Ensure proper patient selection based on FDA-approved indications Educate patients on the benefits and risks of biosimilar therapy Monitor patients closely for response to treatment
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