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

Abstract

Purpose To analyse outcomes of innovator ranibizumab (IRM) (Lucentis) and biosimilar ranibizumab (BRM) (Razumab) in Indian eyes with neovascular age-related macular degeneration (nAMD). Methods Retrospective observational study in nAMD patients, who were treated with IRM or BRM (3 loading doses followed by pro re nata (PRN). Primary outcome measures were change in best corrected visual acuity (BCVA) and central macular thickness (CMT) along with safety analysis. Secondary outcomes measures were changes in the subretinal fluid (SRF) and intraretinal fluid (IRF). Results Inclusion criteria were satisfied in 164 eyes (60.74%). A total of 87 eyes were treated with IRM, and 77 eyes received BRM. Baseline BCVA was 0.57±0.27 logMAR in IRM group and 0.61±0.25 in the BRM group. At 3, 6, 9, and 12 months BCVA was 0.27±0.22 ( p <0.0001), 0.34±0.23 ( p <0.0001), 0.39±0.25 ( p <0.0001), and 12 months 0.41±0.23 ( p <0.0001) in the IRM group and 0.24±0.16 ( p <0.0001), 0.27±0.16 ( p <0.0001), 0.34±0.17 ( p <0.0001), 0.38±0.18 ( p <0.0001) in the BRM group. Baseline CMT was 420.39±54.45 μm in IRM group and 407.82±53.07 μm in BRM group. At 3, 6, 9, and 12 months, CMT decreased to 258.28±20.4 μm ( p <0.0001), 268.38±19.5 μm ( p <0.0001), 269.51±32.41 μm ( p <0.0001), and 278.28±16.56 μm ( p <0.0001) in the IRM group and 258.84±17.47 μm ( p <0.0001), 265.69±17.29 μm ( p <0.0001), 273.64±23.13 μm ( p <0.0001), and 283.09±19.66 μm ( p <0.0001) in the BRM group. Similar improvements in IRF and SRF levels in the patients were noted in both groups. Required number of doses of IRM and BRM was similar over the 12 month period in both groups. A similar profile of adverse events was noted in both the groups. Conclusion Intravitreal injection of IRM and BRM show similar efficacy and safety in Indian eyes with nAMD.

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

“…Moreover, Razumab was evaluated in another retrospective real word study, the Balance Trial, with 164 eyes, which were treated either with the ranibizumab or the biosimilar Razumab. 23 The results showed similar efficacy with significant improvement in BCVA and significant decrease in central macular thickness (CMT) at all time points. The authors noted improvements in SRF and IRF, observing no significant differences in these outcomes between the treatment with ranibizumab and its biosimilar, Razumab.…”

“… No meaningful differences between treatment groups in anatomical, safety, or immunogenicity end points through week 52. Chakraborty et al 2023 23 Razumab ® (Intas Pharmaceuticals, India) 164 BCVA was significantly improved from 0.57±0.27 logMAR to 0.41±0.23 at 12 months in the ranibizumab group and from 0.61±0.25 to 0.24±0.16 in the razumab group. CMT was significantly decreased in the razumab group from 407.82±53.07μm at the baseline to 283.09±19.66 μm at week 12.…”

Efficacy, Safety and Immunogenicity of Sun’s Ranibizumab Biosimilar in Neovascular Age-Related Macular Degeneration: A Phase 3, Double-Blind Comparative Study

“…Another anti-VEGF monoclonal antibody, bevacizumab, an anti-angiogenic in treating solid tumours, is used as an effective off-label treatment at low cost for nAMD [ 27 ]. However, multi-dose vial availability of bevacizumab is leading to problems in aliquoting and storage [ 18 ], and its association with cluster endophthalmitis has been a constant issue [ 28 ]. Also, a recent online survey of members of the Vitreo-Retinal Society of India reported an increase in the use of ranibizumab biosimilars from 41% in 2018 to 56% in 2020 ( p = 0.2) and a simultaneous significant decline in the use of bevacizumab biosimilars from 9% in 2018 to 2% in 2020 ( p = 0.04), indicating a progressive trend favoring ranibizumab biosimilar over bevacizumab biosimilar [ 22 ].…”

“…The purpose of developing biosimilar drugs is to improve the accessibility of such treatments at low cost without compromising the treatment quality [ 18 ]. The World Health Organization has defined biosimilar drugs as biotechnological products with comparable quality to approved reference products supported by clinical and nonclinical evaluation with an approved reference product [ 19 ].…”

Transitioning from Aflibercept to Biosimilar Ranibizumab in Neovascular AMD (The TRANSFORM Trial): A Multicenter Observational Study

“…8 It has shown good efficacy for most retinal disorders in limited studies; more than 100,000 injections have already been used in India alone. 9 While there are reports on the shift from aflibercept to ranibizumab in nAMD non-responsive to aflibercept, 1,3,4 there are no reports of switching to the biosimilar ranibizumab. The purpose of the current study was to analyze how eyes with nAMD respond to switching from aflibercept to the biosimilar ranibizumab.…”