Systematic review and meta-analysis shows aflibercept biosimilars match reference drug efficacy and safety in AMD and DME

This systematic review and meta-analysis compared aflibercept biosimilars with reference aflibercept in patients with neovascular age-related macular degeneration and diabetic macular edema. The analysis included a total sample size of 4064 patients. The primary outcome assessed best-corrected visual acuity changes, while secondary outcomes included central subfield thickness change, choroidal neovascularization size, vision maintenance, anti-drug antibody development, treatment-emergent adverse events, and ocular adverse effects.

Results indicated no significant differences between the biosimilars and the reference drug for best-corrected visual acuity changes in neovascular age-related macular degeneration, with a standard mean difference of -0.04 and a 95% confidence interval of -0.15 to 0.06. Similarly, no significant differences were observed for best-corrected visual acuity changes in diabetic macular edema, with a standard mean difference of 0.11 and a 95% confidence interval of -0.12 to 0.33. No significant differences were reported for central subfield thickness change, choroidal neovascularization size, vision maintenance, anti-drug antibody development, treatment-emergent adverse events, or ocular adverse effects.

The authors note that serious adverse events, discontinuations, and tolerability data were not reported. The study concludes that aflibercept biosimilars offer a cost-effective alternative that provides similar clinical benefits while improving treatment accessibility. Clinicians should interpret these findings as supportive of biosimilar use in this context, pending further long-term data.