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

Abstract

Ranibizumab is approved for the treatment of several macular disorders, including wet age-related macular degeneration (wet AMD), diabetic macular edema (DME), retinal vein occlusion (RVO) and myopic choroidal neovascularization (mCNV), among others. The unaffordability of the innovator ranibizumab among patients from developing countries such as India led to the development of the world’s first biosimilar ranibizumab, which is a cost-effective alternative that does not compromise efficacy and safety. Razumab™, developed and produced by Intas Pharmaceuticals Ltd., India, is the world’s first biosimilar of ranibizumab, and is approved in India for the treatment of various macular disorders, including wet AMD, DME, RVO and mCNV. The efficacy and safety of Razumab for the treatment of these macular disorders have been evaluated in both prospective and real-world retrospective studies. Razumab has shown an efficacy similar to that of the innovator ranibizumab, achieving improved visual acuity, as measured by the best corrected visual acuity, and reduction in the central macular thickness, leading to improved patient outcomes. The safety profile of Razumab is comparable to that of the innovator ranibizumab and is well tolerated without any new safety concerns. Here, we review the clinical and real-world data of Razumab in the treatment of macular disorders.

Long-term efficacy and safety of RazumabTM (biosimilar ranibizumab) in Indian patients with retinal diseases: results from retrospective REAR RD-2 study

“…32 The efficacy and safety of biosimilar ranibizumab in retinal diseases such as wet AMD, DME, RVO and mCNV have been reported in several prospective and retrospective studies in Indian patients. 33 The real-world efficacy and safety of biosimilar ranibizumab in retinal diseases was reported in the RE-ENACT (n=561) and RE-ENACT 2 (n=341) studies. 33 In this current study, the mean BCVA and CSFT showed significant improvements (p<0.0001) in the visual acuity and disease condition.…”

“…33 The real-world efficacy and safety of biosimilar ranibizumab in retinal diseases was reported in the RE-ENACT (n=561) and RE-ENACT 2 (n=341) studies. 33 In this current study, the mean BCVA and CSFT showed significant improvements (p<0.0001) in the visual acuity and disease condition. Also, the percentage of patients with IRF and SRF significantly reduced from baseline to week 48 for all indications after biosimilar ranibizumab treatment.…”

“…In comparison to parent biologic drugs, biosimilar agents lead to 25-50% reduction in the treatment cost. 33 It has been reported that Intas' Razumab TM , biosimilar ranibizumab, (US $125) is a cost-effective alternative to the innovator ranibizumab (US $320), aflibercept (US $760) and brolucizumab (US $350). 36 No clinically significant change in IOP (mm Hg) after biosimilar ranibizumab treatment was noted during the study duration.…”

“…The results are in accordance with the RE-ENACT and RE-ENACT 2 studies, which demonstrated that biosimilar ranibizumab was effective and well-tolerated, with no new safety concerns, in retinal diseases in the real-world Indian settings. 33 The study limitation included a retrospective nature of the study, and data entry at multiple sites potentially leading to inconsistency in the data.…”

Ranibizumab Biosimilars for Neovascular Age-related Macular Degeneration, Macular Oedema with Retinal Vein Occlusion and Myopic Choroidal Neovascularization

“…16.2.80 touchREVIEWS in Ophthalmology sustainable option; biosimilars have an expected high implementation rate, at least in developing countries, though usage in the United States remains to be seen. 5 While biosimilars have only recently entered the ophthalmology scene, biosimilars have successfully been integrated into other medical specialties, such as oncology and dermatology, with the first biosimilar approved by the FDA in 2015. 6 Multiple studies have investigated the use of biosimilars in a variety of retinal conditions, including NvAMD, DMO and mCNV, which this review will cover.…”