FDA Approves Lucentis Biosimilar Nufymco
Ranibizumab-leyk (Nufymco) is approved for all Lucentis indications.
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By
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Conexiant News Staff
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January 2, 2026
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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
References
