Comparison Between Ranibizumab Biosimilar, Innovator Ranibizumab and Bevacizumab in a Real World Situation

Abstract

PurposeTo analyze the efficacy of biosimilar ranibizumab as compared to innovator ranibizumab and bevacizumab.MethodsWe retrospectively analyzed consecutive patients treated with biosimilar ranibizumab for wet age related macular degeneration (AMD) and macular edema (ME) and compared them with ranibizumab and bevacizumab treated patients.ResultsOut of 202 patients, 67 (33.2%) received biosimilar ranibizumab (BSR), 69 (34.2%) ranibizumab (RBZ) and 66 (32.7%) bevacizumab (BEV). All patients received 3 consecutive injections followed by pro re nata dosing. The follow up ranged from 3 -24 months. The mean number of injections were 6.68 RBZ, 6.4 BEV and 4.7 BSR. At 3 months, nAMD (n=115, 56.9%) and ME (n= 87, 43.1%) groups showed significant improvement in vision and central foveal thickness (CFT) across all 3 agents. After ≥ 6 months, the effects were maintained in AMD group but not in ME group. Maximum effect was seen at 1 month. At no point of time, significant difference was noted among the 3 anti VEGF agents. No major safety concerns were noted.ConclusionsBiosimilar ranibizumab is comparable to innovator ranibizumab and bevacizumab in efficacy and safety. It can be added to the list of available anti VEGF agents for the treatment of vascular disorders.

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

“…A retrospective case series compared Razumab™, ranibizumab and bevacizumab in 202 patients with NvAMD, DMO or RVO. 13 Primary outcomes included improvement in BCVA at 3 months, with all three groups showing statistically significant improvement, and with no significant difference noted among the three agents. 13 The largest realworld outcomes study -a multicentre retrospective review of patients with NvAMD, DMO or RVO (6,404 eyes) -focused on the adverse event profile of Razumab™, with a total of 9,406 injections.…”

“…13 Primary outcomes included improvement in BCVA at 3 months, with all three groups showing statistically significant improvement, and with no significant difference noted among the three agents. 13 The largest realworld outcomes study -a multicentre retrospective review of patients with NvAMD, DMO or RVO (6,404 eyes) -focused on the adverse event profile of Razumab™, with a total of 9,406 injections. 20 Of these, 1,978 injections were associated with adverse events, with the serious ocular adverse effects including retinal pigment epithelial tears (31 cases; 0.33%), vitritis (2 cases; 0.02%) and endophthalmitis (1 case; 0.01%).…”

“…Razumab™ is a humanized, recombinant monoclonal antibody produced through Escherichia coli. 13 It has been studied extensively in India in NvAMD, DMO and mCNV, along with other considerations, in both prospective and retrospective studies. According to one report, the cost of Razumab™ is US$175, whereas ranibizumab costs US$322.…”

“…According to one report, the cost of Razumab™ is US$175, whereas ranibizumab costs US$322. 13 ASSET, a phase IV, prospective post-marketing study enrolled 126 Razumab™-treated patients aged >50 years with NvAMD. 14 The primary endpoints included the proportion of patients losing <15 letters in BCVA, and changes in central retinal thickness measured at Week 12 and 24; both were significantly improved at Week 12 and 24.…”

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

“…In recent times, biosimilar compounds have been considered promising alternatives to expensive biological medicines. 20,21 Biosimilar compounds are molecules that are very similar to an original biological product regarding clinical efficacy, immunogenicity, and biosafety. However, biosimilar compounds can have minute variations from the original compound, and safety and effectiveness can be reasons for concern.…”