Chakraborty Debdulal, Sinha Tushar Kanti, Sinha Sourav, Biswas Rupak Kanti, Maiti Aniruddha, Boral Subhendu, Das Arnab, Mandal Soumava, Bhattacharya Ranabir, Dan Shouvick, Rungta Dinesh
Department of Vitreoretinal Services, Disha Eye Hospitals, Kolkata, West Bengal, India.
Department of Vitreoretinal Services, Netralayam Superspeciality Eye Care, Kolkata, West Bengal, India.
Clin Ophthalmol. 2025 Mar 28;19:1093-1102. doi: 10.2147/OPTH.S515479. eCollection 2025.
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.
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.
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).
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.
在一项多中心回顾性研究中，比较生物类似药雷珠单抗（Razumab™）和原研药雷珠单抗（Accentrix™）在治疗脉络膜视网膜血管疾病时，在一个大型、多样化患者队列中的安全性概况。
这项多中心回顾性研究分析了2016年1月至2024年3月期间印度21个中心接受生物类似药或原研药雷珠单抗治疗的39226只眼睛的数据。符合条件的患者因年龄相关性黄斑变性（AMD）、糖尿病性黄斑水肿（DME）、视网膜静脉阻塞（RVO）和近视性脉络膜新生血管（CNVM）等病症接受玻璃体内注射。对患者进行至少三个月的随访，随访期间记录不良事件。基于眼部和全身不良事件评估安全性结果，使用卡方检验和t检验对组间频率进行统计分析。
原研药组共注射46520次（20283只眼；每只眼平均2.29±1.53次注射），生物类似药组共注射45310次（18943只眼；每只眼平均2.39±1.61次注射）。两组显示出相似的安全性概况。眼部不良事件大多为轻度，短暂性视物模糊、结膜下出血和眼痛的发生率相似。严重眼部事件，包括眼内炎，很罕见（每组2例）。全身不良事件，如心肌梗死和脑血管意外，也很罕见，组间无统计学显著差异。生物类似药组前房炎症发生率较高（p=0.005），而该组头痛明显更常见（p=0.0002）。
这项大规模真实世界研究表明，在脉络膜视网膜血管疾病的治疗中，生物类似药雷珠单抗与原研药雷珠单抗具有相似的安全性概况。生物类似药雷珠单抗的可负担性增强了其作为具有成本效益的替代方案的潜力，特别是在资源有限的环境中，且不影响安全性。
