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Purpose <p>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.</p> Methods <p>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.</p> Results <p>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; <i>p</i> = 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; <i>p</i> = 0.09). The proportion losing fewer than 15 BCVA did not differ significantly (RR 0.99; 95% CI 0.98 to 1.00; <i>p</i> = 0.21). CST changes were comparable. Notably, biosimilars reduced CNV size at long-term follow-up (MD -0.39&#xa0;mm²; 95% CI -0.68 to -0.09; <i>p</i> = 0.01). Safety outcomes and ADA incidence were similar between groups.</p> Conclusions <p>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.</p>

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Ranibizumab biosimilars vs. reference Ranibizumab for neovascular age-related macular degeneration: a systematic review and meta-analysis

  • 期刊论文

  • 发表日期：

    2025年10月11日

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  • Nuno Rodrigues Alves,
  • Patrícia Barros Silva,
  • Catarina Barão,
  • Lívio Costa,
  • Helena Donato,
  • Ana Basílio,
  • Rita Flores,
  • Rita Anjos

摘要

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.