CompaRative Safety Analysis of Innovator and BioSimilar Ranibizumab in Chorioretinal Vascular Diseases - The CRsIBS Study.

Abstract

Purpose: To compare the safety profiles of biosimilar ranibizumab (Razumab™) and innovator ranibizumab (Accentrix™) in the management of chorioretinal vascular diseases across a large, diverse patient cohort in a multicenter retrospective study.

Methods: This multicenter, retrospective study analyzed data from 39,226 eyes treated with either biosimilar or innovator ranibizumab across 21 centers in India between January 2016 and March 2024. Eligible patients received intravitreal injections for conditions including age-related macular degeneration (AMD), diabetic macular edema (DME), retinal vein occlusion (RVO), and myopic choroidal neovascularization (CNVM). Patients were followed for a minimum of three months, with adverse events documented during follow-up visits. Safety outcomes were assessed based on ocular and systemic adverse events, with statistical analyses comparing frequencies between groups using chi-square and t-tests.

Results: A total of 46,520 injections were administered in the innovator group (20,283 eyes; mean 2.29±1.53 injections per eye) and 45,310 injections in the biosimilar group (18,943 eyes; mean 2.39±1.61 injections per eye). Both groups showed comparable safety profiles. Ocular adverse events were mostly mild, with similar rates of transient blurring, subconjunctival hemorrhage, and ocular pain. Serious ocular events, including endophthalmitis, were rare (2 cases in each group). Systemic adverse events, such as myocardial infarction and cerebrovascular accidents, were also rare, with no statistically significant differences between groups. A higher incidence of anterior chamber inflammation was noted in the biosimilar group (p=0.005), while headache was significantly more common in this group (p=0.0002).

Conclusion: This large-scale real-world study demonstrates that biosimilar ranibizumab offers a comparable safety profile to innovator ranibizumab in the management of chorioretinal vascular diseases. The affordability of biosimilar ranibizumab enhances its potential as a cost-effective alternative, particularly in resource-limited settings, without compromising safety.