Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2025
Ranibizumab biosimilars vs. reference Ranibizumab for neovascular age-related macular degeneration: a systematic review and meta-analysis.
Систематический обзорСтатьяМетаанализНазвание и аннотация: Перевод пока не подготовлен
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Rodrigues Alves Nuno, Silva Patrícia Barros, Barão Catarina, Costa Lívio, Donato Helena, Basílio Ana, Flores Rita, Anjos Rita
Аннотация
PURPOSE: Neovascular age-related macular degeneration (nAMD) is a leading cause of vision loss, with anti-vascular endothelial growth factor therapy being effective but costly. This systematic review and meta-analysis assessed the efficacy, safety, and immunogenicity of ranibizumab biosimilars versus ranibizumab in nAMD.
METHODS: We systematically searched PubMed, Embase, Cochrane Library, and ClinicalTrials.gov for randomized controlled trials (RCTs) comparing ranibizumab biosimilars with reference ranibizumab in nAMD. Outcomes included: (1) best-corrected visual acuity (BCVA), (2) proportion of patients losing fewer than 15 BCVA letters, (3) central subfield thickness (CST), (4) choroidal neovascularization (CNV) size, (5) safety outcomes, and (6) anti-drug antibodies (ADA). Data were pooled using a random-effects model, and heterogeneity assessed by I².
RESULTS: Ten RCTs (3704 eyes) were included, with 1944 (52.5%) receiving biosimilars. At short-term follow-up (8-16 weeks), biosimilars significantly improved BCVA over reference (MD -0.81 letters; 95% CI -1.41 to -0.21; p = 0.008), although this difference is clinically negligible. At long-term follow-up (48-52 weeks), there was a non-significant trend toward greater BCVA improvement (MD -0.75 letters; 95% CI -1.62 to 0.12; p = 0.09). The proportion losing fewer than 15 BCVA did not differ significantly (RR 0.99; 95% CI 0.98 to 1.00; p = 0.21). CST changes were comparable. Notably, biosimilars reduced CNV size at long-term follow-up (MD -0.39 mm²; 95% CI -0.68 to -0.09; p = 0.01). Safety outcomes and ADA incidence were similar between groups.
CONCLUSIONS: Ranibizumab biosimilars demonstrate comparable safety, immunogenicity, and efficacy to reference ranibizumab. The small short-term BCVA difference is not clinically meaningful, supporting biosimilars as cost-effective alternatives for nAMD.
METHODS: We systematically searched PubMed, Embase, Cochrane Library, and ClinicalTrials.gov for randomized controlled trials (RCTs) comparing ranibizumab biosimilars with reference ranibizumab in nAMD. Outcomes included: (1) best-corrected visual acuity (BCVA), (2) proportion of patients losing fewer than 15 BCVA letters, (3) central subfield thickness (CST), (4) choroidal neovascularization (CNV) size, (5) safety outcomes, and (6) anti-drug antibodies (ADA). Data were pooled using a random-effects model, and heterogeneity assessed by I².
RESULTS: Ten RCTs (3704 eyes) were included, with 1944 (52.5%) receiving biosimilars. At short-term follow-up (8-16 weeks), biosimilars significantly improved BCVA over reference (MD -0.81 letters; 95% CI -1.41 to -0.21; p = 0.008), although this difference is clinically negligible. At long-term follow-up (48-52 weeks), there was a non-significant trend toward greater BCVA improvement (MD -0.75 letters; 95% CI -1.62 to 0.12; p = 0.09). The proportion losing fewer than 15 BCVA did not differ significantly (RR 0.99; 95% CI 0.98 to 1.00; p = 0.21). CST changes were comparable. Notably, biosimilars reduced CNV size at long-term follow-up (MD -0.39 mm²; 95% CI -0.68 to -0.09; p = 0.01). Safety outcomes and ADA incidence were similar between groups.
CONCLUSIONS: Ranibizumab biosimilars demonstrate comparable safety, immunogenicity, and efficacy to reference ranibizumab. The small short-term BCVA difference is not clinically meaningful, supporting biosimilars as cost-effective alternatives for nAMD.