Biosimilar Ranibizumab Performs on Par With Innovator Drug Across Retinal Diseases

A multicenter retrospective study spanning nearly 5000 eyes across 5 tertiary eye-care centers in India has added substantial real-world weight to the case that biosimilar ranibizumab can serve as a viable, lower-cost alternative to the innovator drug for treating a range of vision-threatening retinal conditions.¹

This study was published in Pharmaceuticals.

Nearly 5000 eyes and nearly 21,000 injections show comparable vision, anatomical, and safety outcomes between Ranieyes and Lucentis/Accentrix. | Image credit: Viktor - stock.adobe.com

“Much of the available evidence is disease-specific, noncomparative, or limited by relatively short follow-up,” wrote the researchers of the study. “In addition, fewer multicenter real-world studies have evaluated a single ranibizumab biosimilar brand against innovator ranibizumab across heterogeneous retinal vascular diseases while simultaneously examining longitudinal outcomes, treatment burden, and safety. This gap provided the rationale for the present study.”

The study compared outcomes between biosimilar ranibizumab (Ranieyes; Lupin Pharmaceuticals) and innovator ranibizumab (Lucentis/Accentrix; Novartis) in 4997 eyes from 3577 patients treated between July 2022 and October 2025. The biosimilar arm included 2543 eyes (10,893 injections), while the innovator arm included 2454 eyes (10,136 injections). Patients were treated for neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), branch and central retinal vein occlusion (BRVO/CRVO), myopic choroidal neovascularization (mCNV), and an exploratory group receiving anti-VEGF therapy as a preoperative adjunct before vitreoretinal surgery.

Comparable Vision and Anatomical Outcomes

Across nearly all disease categories, both drugs produced a similar pattern: rapid improvement in best-corrected visual acuity (BCVA) and reduction in central subfield thickness within the first 3 months, followed by long-term stabilization through 24 months. In DME, BRVO, CRVO, and mCNV, the visual acuity trajectories of the 2 groups tracked closely together at every follow-up visit. The nAMD subgroup showed 1 statistically notable gap—a slightly better BCVA in the biosimilar group at 12 months—but the researchers noted the difference was small in magnitude and did not persist at 18 or 24 months, making it unlikely to reflect a true clinical distinction between the drugs.

Similar Treatment Burden

The number of injections needed over the study period was nearly identical between groups for DME, nAMD, and CRVO. Small but statistically significant differences emerged in BRVO and mCNV, although the researchers cautioned that real-world retreatment decisions are shaped by cost, logistics, and physician judgment rather than a fixed protocol, so these gaps should not be overinterpreted.

Across more than 21,000 total injections, serious complications were rare in both arms. Endophthalmitis, the most feared injection-related complication, occurred in only 1 of 10,893 biosimilar injections vs 2 of 10,136 innovator injections—a difference with no statistical significance. Rates of retinal pigment epithelial tears, intraocular inflammation, and serious systemic vascular events such as myocardial infarction and stroke were also similar between groups, and the authors reported no new safety signal for the biosimilar.

Why It Matters

The economic case is central to the study's relevance. At the participating Indian hospitals, innovator ranibizumab cost roughly $270 to $325 per injection compared with about $129 to $173 for the biosimilar—a discount that could meaningfully affect treatment continuity in settings where repeated injections over years strain patient budgets. Because retinal vascular diseases are chronic and relapsing, requiring long-term anti–vascular endothelial growth factor therapy, affordability directly affects whether patients keep up with the injection schedules needed to preserve vision.

This Indian cohort adds to a growing body of real-world data on ranibizumab biosimilars internationally. A related multicenter study in South Korea, the ROSE Korea study, evaluated 2 regulatory-approved biosimilars—Amelivu and LucenBS—and similarly found outcomes broadly comparable to reference ranibizumab, while noting that such biosimilars generally offer a 20% to 30% cost reduction compared with the originator product.²

Together, these studies suggest that as more ranibizumab biosimilars clear regulatory bars around the world, clinicians are accumulating the kind of large-scale, real-world reassurance that tends to drive broader adoption—provided prescribers keep in mind that each biosimilar brand still needs its own body of evidence, since findings from one product don't automatically transfer to another.

“These findings should be interpreted as supportive observational comparative evidence rather than formal proof of equivalence,” wrote the researchers.¹ “Because this study evaluated a single biosimilar brand, the results should not be generalized to all ranibizumab biosimilars. Further adjusted, disease-specific multicenter comparative studies across different biosimilar brands are warranted.”

References

1. Chakraborty D, Sinha TK, Sinha S, et al. Real-world comparison of biosimilar ranibizumab (Ranieyes) and innovator ranibizumab (Lucentis/Accentrix) across multiple retinal vascular diseases (the BRIO study). Pharmaceuticals (Basel). 2026;19(5):747. doi:10.3390/ph19050747
2. Song JR, Park UC, Lee CS, et al. Real-world outcomes of ranibizumab biosimilars in various retinal diseases: a Korean multi-center experience-ROSE Korea Study. Sci Rep. 2026;16(1):4220. doi:10.1038/s41598-025-34325-4