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Background <p>Neovascular age-related macular degeneration (AMD) is a leading cause of irreversible vision loss among the elderly. Current treatment options include intravitreal anti-VEGF therapy with ranibizumab and aflibercept. These medications are very effective but expensive. Biosimilars of these expensive intravitreal medications have been proposed as less expensive treatment options. However, their clinical equivalence and safety are of concern.</p> Purpose <p>The purpose of this study was to assess the efficacy, safety, and immunogenicity of biosimilars of ranibizumab and aflibercept, and their clinical equivalence with their reference biologics, in the treatment of neovascular AMD.</p> Methods <p>We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) comparing biosimilar anti-VEGF agents with reference ranibizumab or aflibercept. A comprehensive search of PubMed, Scopus, and Cochrane Library (inception–September 2025) was performed following PRISMA guidelines. Outcomes included change in best-corrected visual acuity (BCVA) at 12&#xa0;weeks and study endpoint, ≥ 15-letter responder rates, treatment-emergent anti-drug antibodies (ADAs), and ocular/serious ocular adverse events. Risk of bias was assessed using the Cochrane ROB-2 tool.</p> Results <p>Seventeen phase 3 RCTs including 6694 patients were analyzed. Pooled results showed no clinically meaningful differences in BCVA improvement at 12 weeks (MD = − 0.42, <i>p</i> = 0.17) or at study endpoint (MD = − 0.32, <i>p</i> = 0.23) between biosimilars and reference biologics. Responder rates (≥ 15-letter gain) were comparable (RR = 1.06, <i>p</i> = 0.36), as were rates of treatment-emergent ADAs (RR = 0.89, <i>p</i> = 0.40) and ocular adverse events (RR = 0.99, <i>p</i> = 0.86). The subgroup analysis did not demonstrate significant results for biosimilars of aflibercept compared with the reference aflibercept; however, biosimilars of ranibizumab had slightly less BCVA improvement at the end point (RR 0.53, <i>p</i> 0.02). Heterogeneity was low to moderate, and no publication bias was noted.</p> Conclusion <p>Our analysis has demonstrated that biosimilars of ranibizumab and aflibercept have equivalent efficacy, safety, and immunogenicity profiles compared with the reference biologics. Future studies should focus on long-term outcomes, switching studies, and health economics to help determine the long-term success of biosimilar therapy.</p>

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Clinical efficacy and safety of anti-VEGF biosimilars compared to reference anti-VEGF agents for neovascular age-related macular degeneration: a systematic review, meta-analysis, and meta-regression

  • 期刊论文

  • 发表日期：

    2026年3月20日

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  • Yousef Mesaed Al-Shammari,
  • Yousef M. AlDhafiri,
  • Abdullah Kamal Ahmad,
  • Basel Bader Alkharraz,
  • Mohammed Ahmad Al-Awadhi,
  • Rashed Mesaed Alnabhan

摘要

Background

Neovascular age-related macular degeneration (AMD) is a leading cause of irreversible vision loss among the elderly. Current treatment options include intravitreal anti-VEGF therapy with ranibizumab and aflibercept. These medications are very effective but expensive. Biosimilars of these expensive intravitreal medications have been proposed as less expensive treatment options. However, their clinical equivalence and safety are of concern.

Purpose

The purpose of this study was to assess the efficacy, safety, and immunogenicity of biosimilars of ranibizumab and aflibercept, and their clinical equivalence with their reference biologics, in the treatment of neovascular AMD.

Methods

We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) comparing biosimilar anti-VEGF agents with reference ranibizumab or aflibercept. A comprehensive search of PubMed, Scopus, and Cochrane Library (inception–September 2025) was performed following PRISMA guidelines. Outcomes included change in best-corrected visual acuity (BCVA) at 12 weeks and study endpoint, ≥ 15-letter responder rates, treatment-emergent anti-drug antibodies (ADAs), and ocular/serious ocular adverse events. Risk of bias was assessed using the Cochrane ROB-2 tool.

Results

Seventeen phase 3 RCTs including 6694 patients were analyzed. Pooled results showed no clinically meaningful differences in BCVA improvement at 12 weeks (MD = − 0.42, p = 0.17) or at study endpoint (MD = − 0.32, p = 0.23) between biosimilars and reference biologics. Responder rates (≥ 15-letter gain) were comparable (RR = 1.06, p = 0.36), as were rates of treatment-emergent ADAs (RR = 0.89, p = 0.40) and ocular adverse events (RR = 0.99, p = 0.86). The subgroup analysis did not demonstrate significant results for biosimilars of aflibercept compared with the reference aflibercept; however, biosimilars of ranibizumab had slightly less BCVA improvement at the end point (RR 0.53, p 0.02). Heterogeneity was low to moderate, and no publication bias was noted.

Conclusion

Our analysis has demonstrated that biosimilars of ranibizumab and aflibercept have equivalent efficacy, safety, and immunogenicity profiles compared with the reference biologics. Future studies should focus on long-term outcomes, switching studies, and health economics to help determine the long-term success of biosimilar therapy.