Efficacy and safety of aflibercept biosimilars compared to aflibercept in the treatment of neovascular age-related macular degeneration: a systematic review and meta-analysis.

BACKGROUND

This study aimed to evaluate the aflibercept biosimilars compared to the reference product aflibercept (Eylea®) in terms of efficacy, safety, and immunogenicity in patients with neovascular age-related macular degeneration (nAMD).

METHODS

We searched PubMed, Web of Science, Cochrane Library, and Embase from inception to 13 August 2025. We included studies reporting changes in best-corrected visual acuity (BCVA), changes in central subfield thickness (CST), changes in the leakage lesion of choroidal neovascularization (CNV), and adverse events from baseline to endpoint. All statistical analyses were performed using Stata 18.0 software and assessed the certainty of evidence for each outcome using the GRADE approach.

RESULTS

A total of seven studies involving 2,829 participants were included. There were no statistically significant differences in visual and anatomical outcomes between the aflibercept biosimilars (SB15, P041, SDZ-AFL, AVT06, SCD411, ABP 938, and QL1207) and the reference aflibercept. No significant differences were detected between aflibercept biosimilars and the reference aflibercept with respect to serious ocular and non-ocular adverse events [relative risk (RR) = 1.71, 95% confidence interval (CI): 0.70, 4.19; I 2 = 0.0%, P = 0.913; RR = 1.08, 95% CI: 0.82, 1.42; I 2 = 0.0%, P = 0.936, respectively). Although a slightly higher rate of treatment-emergent adverse events (TEAEs) was noted in the biosimilar group (RR = 1.07, 95% CI: 1.00-1.15; I2 = 26.1%), the difference was not statistically significant (P = 0.248).

CONCLUSION

Based on the seven included randomized controlled clinical trials, aflibercept biosimilars demonstrated comparable safety and efficacy to the reference aflibercept. Future research requires more rigorous studies.