Clinical efficacy and safety of Razumab® (CESAR) study

Abstract

Purpose: The aim of this study was to evaluate the efficacy and safety of Razumab (the biosimilar Ranibizumab by Intas Pharmaceuticals Ltd.) for the treatment of chorioretinal vascular diseases such as diabetic macular edema (DME), choroidal neovascular membrane (CNVM), and macular edema secondary to retinal vein occlusion (RVO). Methods: We conducted a single-center, retrospective study, including patients with DME, CNVM, and RVO, who had received treatment with Razumab® between October 2018 and September 2019. Primary outcome measures were the changes in corrected distance visual acuity (CDVA) and central foveal thickness (CFT) from baseline to 1 month and 3 months. Secondary outcome measures included intraocular pressure (IOP) at day 1, any signs of ocular inflammation or systemic adverse events during the follow-up. Results: One hundred and fifty-three eyes of 141 patients were analyzed. The indications included DME in 70 (45.8%) eyes, CNVM in 70 (45.8%) eyes, and RVO in 13 (8.4%) eyes. Mean CDVA improved from baseline (0.62 ± 0.44) to month 1 (0.45 ± 0.42) and maintained till 3 months (0.42 ± 0.44; P < 0.001). Mean CFT showed significant reduction from baseline (405.68 ± 192.422 μm) to month 1 (286.08 ± 118.36 μm) and month 3 (271 ± 104.24 μm; P < 0.001). None of the eyes recorded IOP >20 mmHg on day 1. No evidence of ocular toxicity or systemic adverse event was noted. Conclusion: Razumab® showed a rapid improvement in CDVA and CFT in most of the eyes with efficacy observed as early as 1 month and maintained till 3 months. The biosimilar Ranibizumab can be a safe and effective low-cost drug for treating macular diseases.

Treatment Landscape of Macular Disorders in Indian Patients with the Advent of Razumab™ (World’s First Biosimilar Ranibizumab): A Comprehensive Review

“…The advent of anti-VEGF biologics, such as ranibizumab, aflibercept, brolucizumab and bevacizumab (off-label), has revolutionized the management of macular discorders [ 20 , 21 , 37 ]. Anti-VEGF agents inhibit vascular permeability, endothelial cell proliferation and endothelial cell migration, and penetrate the retina to block isoforms of VEGF-A [ 38 – 40 ].…”

“…The availability of innovator ranibizumab (Lucentis ® ) to many patients is limited due to its high cost, especially to patients in developing countries such as India [ 37 ]; it is this financial burden which is a major reason for patient non-compliance to the treatment [ 63 ]. The advent of a biosimilar agent has paved the way to democratize the existing expensive medical need [ 64 ].…”

“…Biosimilar agents are cost-effective as they are developed at approximately one-tenth of the cost of biologics, and their marketing price tag is 20–40% lower than that of biologics [ 64 ]. Biosimilars can potentially reduce healthcare expenditures, thus allowing a larger patient population to reap benefits [ 37 ].…”

“…Compared to parent biologic drugs, the use of biosimilar agents may lead to 25–50% decrease in the treatment cost [ 65 ]. For example, the cost of Razumab is approximately 40% lower than that of its innovator product [ 37 ]. In India, Razumab (US $125) is an economical alternative to the innovator ranibizumab (US $320), aflibercept (US $760) and brolucizumab (US $350) [ 65 ].…”

“…In India, Razumab (US $125) is an economical alternative to the innovator ranibizumab (US $320), aflibercept (US $760) and brolucizumab (US $350) [ 65 ]. The total annual cost of treatment was estimated to be US $2700–3700 for innovator ranibizumab versus US $1600–1900 for Razumab in an analysis conducted by Verma et al [ 37 , 66 ]. An online VIBE survey evaluating the perceptions of retina specialists on the use of anti-VEGF biosimilars in India showed an increased acceptance of the efficacy and safety of Razumab from 2018 to 2020 [ 67 ].…”