REVIEW article
Front. Pharmacol.
Sec. Drug Metabolism and Transport
This article is part of the Research TopicClinical Trials in Drug Metabolism and Transport: 2025View all articles
Efficacy and Safety of Aflibercept Biosimilars Compared to Aflibercept in the Treatment of Neovascular Age-Related Macular Degeneration: A Systematic Review and Meta-Analysis
Provisionally accepted
- 1Department of Ophthalmology, Affiliated Xinhua Hospital of Dalian University, Dalian, China
- 2Department of Ophthalmology, Traditional Chinese Medicine Hospital of Kunshan, Kunshan, China
- 3Tianjin Key Laboratory of Retinal Functions and Diseases, Tianjin Branch of National Clinical Research Center for Ocular Disease, Eye Institute and School of Optometry, Tianjin Medical University Eye Hospital, Tianjin, China
- 4Department of Ophthalmology, Shanghai Heping Eye Hospital, Shanghai University, Shanghai, China
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Background: The objective of this study is 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, Embase from inception to 13th Aug 2025. We included studies reporting changes in best-corrected visual acuity (BCVA), changes in central subfield retinal 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 2829 participants were included. There were no statistically significant differences between the aflibercept biosimilars (SB15, P041, SDZ-AFL, AVT06, SCD411, ABP 938, QL1207) and the reference aflibercept for visual and anatomical outcomes. No significant differences were detected between aflibercept biosimilars and reference aflibercept for serious ocular and non-ocular adverse events (relative risk [RR] = 1.71, 95%, confidence interval [CI]: 0.70, 4.19; I2 = 0.0%, P = 0.913; RR = 1.08, 95% CI: 0.82, 1.42; I2 = 0.0%, P = 0.936, respectively). Although a slightly higher rate of treatment-emergent adverse events (TEAEs) was noted in the biosimilars group (RR = 1.07, 95% CI: 1.00–1.15; I² = 26.1%), the difference was not statistically significant (P = 0.248). Conclusions: 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
Keywords: Aflibercept, anti-VEGF therapy, Best-corrected visual acuity, biosimilars, Meta-analysis, neovascular age-related macular degeneration, randomized controlled trials
Received: 06 Oct 2025; Accepted: 06 Jan 2026.
Copyright: © 2026 LIU, Zhou, Wang and Zhan. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: CHEN LIU
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