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Real-World Comparison of Biosimilar Ranibizumab (Ranieyes) and Innovator Ranibizumab (Lucentis/Accentrix) Across
Debdulal Chakraborty1, Tushar Kanti Sinha1, Sourav Sinha2
1Disha Eye Hospitals, Kolkata 700029, India.
Pharmaceuticals (Basel, Switzerland)
|May 27, 2026
Summary
This study found that biosimilar ranibizumab (Ranieyes) demonstrated comparable visual acuity and anatomical outcomes to innovator ranibizumab (Lucentis/Accentrix) in treating retinal vascular diseases. Safety profiles were similar, suggesting biosimilar ranibizumab is a viable alternative for managing these conditions.
Area of Science:
- Ophthalmology
- Vascular Biology
- Pharmacology
Background:
- Retinal vascular diseases like nAMD, DME, RVO, and mCNV necessitate frequent anti-VEGF injections.
- Innovator ranibizumab is effective but poses long-term affordability challenges.
Purpose of the Study:
- To compare functional, anatomical, treatment burden, and safety outcomes between biosimilar ranibizumab (Ranieyes) and innovator ranibizumab (Lucentis/Accentrix).
Main Methods:
- A multicenter retrospective study of 4997 eyes across 3577 patients in India over 24 months.
- Compared biosimilar (1812 patients) and innovator (1765 patients) ranibizumab groups for nAMD, DME, RVO, mCNV.
- Assessed best corrected visual acuity (BCVA), central subfield thickness (CST), injection burden, and adverse events.
Main Results:
- Both groups achieved early BCVA and CST improvements, followed by stabilization.
- Inter-group differences were minor, transient, and clinically insignificant.
- Serious ocular and systemic adverse events were infrequent, with no new safety concerns identified.
Conclusions:
- Biosimilar ranibizumab (Ranieyes) exhibited comparable real-world outcomes to innovator ranibizumab in major retinal disease subgroups.
- Findings suggest biosimilar ranibizumab is a comparable treatment option, though not formal proof of equivalence.
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