Comparison of Innovator vs. Biosimilar Ranibizumab in Treating Diabetic Macular Edema: A Multicenter Retrospective Study

Abstract

Introduction: To compare the efficacy of innovator ranibizumab (iRBZ-Accentrix, Novartis, India) vs. biosimilar ranibizumab (bRBZ, Razumab-Intas, India) in eyes with diabetic macular edema (DME) in an Indian population. Methods: Data of patients with DME who underwent at least three injections of iRBZ or bRBZ and had a minimum of 6 months followup were obtained from an electronic database. Choice of injection depended upon the patient. Pro re nata (PRN) protocol from baseline was used with reinjections advised if the central macular thickness (CMT) was at least 300 lm and best corrected visual acuity (BCVA) was 20/40 or worse. Primary outcome measure was comparison of change in BCVA at 6 months between iRBZ and bRBZ. Results: We included 264 eyes in the iRBZ group and 69 eyes in bRBZ group, which were comparable for baseline characteristics. Mean BCVA improved from 0.64 ± 0.39 logMAR to 0.47 ± 0.31 logMAR (p \ 0.001) in the iRBZ group and from 0.71 ± 0.42 logMAR to 0.50 ± 0.29 logMAR in the bRBZ group (p \ 0.001) at 6 months. There were no differences in BCVA between the two groups (p [ 0.05 for all time points). The CMT reduction in the iRBZ group (120 ± 196 lm) was comparable to that in the bRBZ group at

Ranibizumab Biosimilars in Treating Retinal Disorders: A Cost-Effective Revolution?

“…Regarding diabetic macular edema, the biosimilar Razumab (from Razumab-Intas, India) was compared with the reference Ranibizumab in a study involving 333 eyes from 303 patients. 29 Treatment with Razumab showed an improvement in the mean BCVA at 6 months from 0.64 ± 0.39 logMAR to 0.47 ± 0.31 logMAR, similar to the reference group with 0.50 ± 0.29 logMAR from 0.71 ± 0.42 logMAR. As for CMT, an overall reduction by 117 ± 196 µm at the last follow-up was reported, with no statistically significant differences between Razumab and the reference ranibizumab.…”

“… The cumulative incidence of recurrence of neovascularization was significantly superior in eyes with APROP (43%, 95% CI = 27%–63%) compared to eyes without APROP (13.4%, 95% CI, 8%-22%) ( P < 0.001). Chakraborty et al 2022 29 Razumab ® Intas Pharmaceuticals, India 333 DME Mean BCVA improved from 0.71 ± 0.42 logMAR to 0.50 ± 0.29 logMAR in the bRBZ group ( p < 0.001) at 6 months. There were no differences in BCVA compared to innovator ranibizumab ( p > 0.05 for all time points).…”

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

“…23 Finally, the real-world outcomes of Razumab™ compared with ranibizumab in DMO were retrospectively evaluated in 69 eyes (Razumab™) and 264 eyes (ranibizumab), with the primary outcome being change in BCVA at 6 months. 24 Both groups showed significant improvement from baseline in BCVA, and no significant difference was shown between groups. CST also improved in both groups, without significant differences between them.…”

Biosimilar versus InnovAtor MoLecule of RAnibizumab in Neovascular Age-Related MaCular DEgeneration (The BALANCE Trial): Real-World Evidence

“…have been found to be contributing factors toward patient non-compliance in developing countries. 31 , 34 Non-adherence to treatment can significantly affect the outcome of anti-VEGF therapy in retinal vascular diseases, leading to inferior treatment outcomes in real-life scenarios compared to that from randomized clinical trials. 35 A comparative study by Ehlken et al revealed that appropriate adherence to treatment and follow-up regimens results in better maintenance of visual acuity in DME or nAMD patients.…”

“…20,[26][27][28][29][30] Our group has published the comparable efficacy of Razumab to innovator ranibizumab in the treatment of diabetic macular edema (DME). 31 However, to the best of our knowledge, there are no comparative studies showing the efficacy of this biosimilar (BRM) with the innovator ranibizumab (IRM) molecule with up to 1-year follow-up.…”