Safety and efficacy of Razumab – The new biosimilar in India: Our experience

Sameera, VV; Ag, Apoorva; Joshi, Shrinivas; Guruprasad, A S

doi:10.4103/kjo.kjo_18_17

Cited by 23 publications

(32 citation statements)

References 1 publication

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Razumab, the world's first biosimilar ranibizumab, has shown effectiveness for various vitreoretinal disorders in both prospective [18] and retrospective real-world studies [19]. The RE-ENACT (n = 561) study, a multicenter, retrospective study, strengthened the effectiveness of biosimilar ranibizumab in vitreoretinal disorders in Indian patients in routine clinical settings.…”

Section: Discussionmentioning

confidence: 99%

“…The world's first biosimilar ranibizumab Razumab TM was developed by Intas Pharmaceuticals Ltd. to provide a cost-effective alternative which is accessible to patients with retinal disorders [17], and it was approved by the highest Indian regulatory body, the Drug Controller General of India, in 2015. A prospective study has demonstrated the efficacy and safety of biosimilar ranibizumab in Indian patients with chorioretinal vascular diseases including wet AMD [18].…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

A Multicenter, Retrospective Study (RE-ENACT 2) on the Use of Razumab™ (World’s First Biosimilar Ranibizumab) in Wet Age-Related Macular Degeneration

2019

View full text Add to dashboard Cite

Introduction: The REal life assessmENt of safety And effeCTiveness of Razumab (RE-ENACT) and long-term RE-ENACT 2 retrospective studies have evaluated the use of Razumab TM (world's first biosimilar ranibizumab) in retinal disorders in Indian patients. This report presents the subgroup analysis from the RE-ENACT 2 study in patients with wet age-related macular degeneration (wet AMD). Methods: Medical charts of patients administered biosimilar ranibizumab injections as PRN treatment regimen between September 2015 and June 2018, at 17 centers across India, were reviewed. Changes from baseline in best-corrected visual acuity (BCVA, based on Snellen's or logMAR chart), central subfield thickness (CSFT), intraocular pressure (IOP), and

show abstract

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

A Multicenter, Retrospective Study (RE-ENACT 2) on the Use of Razumab™ (World’s First Biosimilar Ranibizumab) in Wet Age-Related Macular Degeneration

2019

View full text Add to dashboard Cite

show abstract

“…Razumab™, the world’s first biosimilar ranibizumab developed by Intas Pharmaceuticals Ltd., Ahmedabad, India, is a cost-effective alternative, is easily accessible to patients, and was approved by the Drug Controller General of India in 2015 for the treatment of RVO, wet age-related macular degeneration (wet AMD), diabetic macular edema (DME), and myopic choroidal neovascularization (mCNV). The efficacy and safety of biosimilar ranibizumab have been also evaluated in a prospective study in Indian patients with chorioretinal vascular diseases including RVO [ 14 ].…”

Section: Introductionmentioning

confidence: 99%

A Multicenter, Retrospective Study (RE-ENACT 2) on Razumab™ (World's First Biosimilar Ranibizumab) in Retinal Vein Occlusion

2020

View full text Add to dashboard Cite

Purpose The REal life assessmENt of safety And effeCTiveness of Razumab 2 (RE-ENACT 2) study evaluated the long-term effectiveness of biosimilar ranibizumab. We present the subgroup analysis of patients with retinal vein occlusion (RVO). Methods Data of patients who received pro re nata (PRN) biosimilar ranibizumab (November 2015 to December 2018, 17 centers) were analyzed. Endpoints were change from baseline in best corrected visual acuity (BCVA, Snellen’s/logMAR), central subfield thickness (CSFT), intraocular pressure (IOP), and proportions of patients having intraretinal fluid (IRF) and subretinal fluid (SRF) at weeks 4, 8, 12, 16, 20, 24, 30, 36, and 48. Results Of 101 patients, 48.51% were men, and the majority (79.21%) were treatment naïve and had received 3 (range 1–5) injections (53.5%). Significant improvements ( P < 0.05) were observed from baseline to all timepoints for BCVA [baseline, 0.89 ± 0.06 ( n = 94); week 48, 0.41 ± 0.08 ( n = 14)] and CSFT [baseline, 527.58 ± 19.9 ( n = 85); week 48, 307.47 ± 16.4 ( n = 15)]. Changes in IOP (mmHg) were non-significant [baseline, 15.38 ± 0.4 ( n = 94); week 48, 13.94 ± 0.6 ( n = 16); P = 0.5575). Proportions of patients having IRF [baseline, 71.3% ( n = 84) vs week 48, 0% ( n = 15)] and SRF [baseline, 52.5% ( n = 83) vs week 48, 0% ( n = 15)] were decreased. Similar results for BCVA, CSFT, IOP, IRF, and SRF were observed for BRVO and CRVO subgroups. There were no new safety concerns. Conclusions Biosimilar ranibizumab demonstrated improvements in visual acuity and disease outcomes up to 48 weeks in patients with RVO without any new safety concerns. Electronic supplementary material The online version of this article (10.1007/s40123-020-00277-3) contains supplementary material, which is available to authorized users.

show abstract

“…The efficacy and tolerability of Razumab ® has been demonstrated in a prospective study in Indian patients with chorioretinal vascular diseases including RVO [25]. However, these studies are done in a controlled clinical environment and may not reflect data from an actual clinical setting.…”

Section: Introductionmentioning

confidence: 99%

Real-Life Clinical Effectiveness of Razumab® (the World’s First Biosimilar of Ranibizumab) in Retinal Vein Occlusion: A Subgroup Analysis of the Pooled Retrospective RE-ENACT Study

Sharma¹,

Khan²,

Chaturvedi³

2018

Ophthalmologica

View full text Add to dashboard Cite

Background: This subgroup analysis of the RE-ENACT study evaluates the effectiveness of Razumab® (the world’s first biosimilar of ranibizumab by Intas Pharmaceuticals Ltd.) in Indian patients with retinal vein occlusion (RVO). Methods: The data on patients with RVO who had received ≥3 injections of Razumab® between January and August 2016 were analyzed. Endpoints were: improvement in best corrected visual acuity (BCVA), and a decrease in central macular thickness (CMT), intraretinal fluid (IRF), and subretinal fluid (SRF) from baseline at weeks 4, 8, and 12. Results: Of 160 patients, the majority (61.87%) were men. The mean (±SE) BCVA improved from baseline (0.76 ± 0.04) to week 4 (0.73 ± 0.03; p = 0.0656), which attained significance at week 8 (0.55 ± 0.02; p < 0.0001) and week 12 (0.47 ± 0.02; p < 0.0001). The mean (±SE) CMT significantly decreased from baseline (447.60 ± 10.91 μm) to week 4 (431.84 ± 10.92 μm; p = 0.0028), week 8 (339.28 ± 8.12 μm; p < 0.0001), and week 12 (298.23 ± 6.68 μm; p < 0.0001). The proportion of patients with IRF and SRF significantly (p < 0.0001) decreased from baseline to weeks 4, 8, and 12 (IRF: from 70.63 to 45.63, 39.38, and 30.00%, respectively; SRF: from 65.63 to 37.50, 28.13, and 24.38%, respectively). A subgroup analysis of branch RVO and central RVO showed similar results. No new safety concerns were observed. Conclusion: Razumab® (biosimilar of ranibizumab) effectively improved visual acuity and disease outcomes in patients with RVO in a real-world setting with no new safety concerns.

show abstract

Safety and efficacy of Razumab – The new biosimilar in India: Our experience

Cited by 23 publications

References 1 publication

A Multicenter, Retrospective Study (RE-ENACT 2) on the Use of Razumab™ (World’s First Biosimilar Ranibizumab) in Wet Age-Related Macular Degeneration

A Multicenter, Retrospective Study (RE-ENACT 2) on the Use of Razumab™ (World’s First Biosimilar Ranibizumab) in Wet Age-Related Macular Degeneration

A Multicenter, Retrospective Study (RE-ENACT 2) on Razumab™ (World's First Biosimilar Ranibizumab) in Retinal Vein Occlusion

Real-Life Clinical Effectiveness of Razumab® (the World’s First Biosimilar of Ranibizumab) in Retinal Vein Occlusion: A Subgroup Analysis of the Pooled Retrospective RE-ENACT Study

Contact Info

Product

Resources

About