Systematic review of efficacy and meta-analysis of safety of ranibizumab biosimilars relative to reference ranibizumab anti-VEGF therapy for nAMD treatment

• Published in: BMJ open ophthalmology 2023-06, Vol.8 (1), p.e001205
• Main Authors: Hatamnejad, Amin, Dadak, Rohan, Orr, Samantha, Wykoff, Charles, Choudhry, Netan
• Format: Article
• Language: English
• Subjects: Age; Angiogenesis Inhibitors - adverse effects; Bevacizumab - adverse effects; Biological products; Biosimilar Pharmaceuticals - adverse effects; FDA approval; Humans; Macula; Macular degeneration; Meta-analysis; Observational Studies as Topic; Patients; Ranibizumab - adverse effects; Receptors, Vascular Endothelial Growth Factor - therapeutic use; Retina; Systematic review; Vascular endothelial growth factor; Vascular Endothelial Growth Factor A; Vascular Endothelial Growth Factors; Visual acuity
• ISSN: 2397-3269; 2397-3269
• DOI: 10.1136/bmjophth-2022-001205

TopicThis systematic review and meta-analysis provides a summary of the efficacy and safety of ranibizumab biosimilars relative to reference ranibizumab anti-vascular endothelial growth factor (VEGF) therapy for the treatment of neovascular age-related macular degeneration (nAMD).MethodsWe conducted systematic searches from January 2003 to August 2022 on Ovid MEDLINE, EMBASE and the Cochrane Controlled Register of Trials. We included studies reporting changes in early treatment diabetic retinopathy study-measured best-corrected visual acuity (BCVA), number of patients who lost or gained more than 15 letters in BCVA from baseline, changes in retinal thickness and adverse events between treatment arms. The following studies were excluded: studies that did not report visual outcomes following biosimilar and reference ranibizumab intravitreal injections, study arms combining anti-VEGF agents with laser or steroid injections, sham injections as a control comparator, studies without English full texts and non-comparative, observational study design.ResultsFive studies reported on four randomised controlled trials (RCTs) and 1544 eyes at baseline were included in this systematic review and meta-analysis. The studies in our systematic review found no significant differences between reference ranibizumab and ranibizumab biosimilar medications (FYB201, SB11, RanizuRel and Lupin’s ranibizumab) for visual and anatomical outcomes. No significant differences were detected between biosimilar and reference ranibizumab for treatment emergent adverse events (risk ratio, RR 1.06, 95% CI (0.91 to 1.23), p=0.45, I2=52%) or IOP-related adverse events with significant heterogeneity (RR 2.59, 95% CI (0.11 to 62.25), p=0.56, I2=76%).ConclusionThis systematic review of four RCTs demonstrated no significant difference in visual outcomes, retinal thickness outcomes, as well as meta-analysis of adverse events between biosimilar and reference ranibizumab therapies for nAMD treatment.