Efficacy and safety of aflibercept biosimilars compared to reference aflibercept for retinal diseases: A systematic...

Aflibercept biosimilars offer cost-effective alternatives to reference aflibercept for retinal diseases such as neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME). By inhibiting vascular endothelial growth factor-mediated vascular damage, they aim to improve visual outcomes with comparable safety and efficacy, increasing treatment access while reducing cost burden. We evaluate their performance against the reference drug. A comprehensive search was done across Cochrane, Embase, PubMed, Scopus and ClinicalTrials.gov. Randomized controlled trials were included, and quality was assessed via RoB 2.0 tool. A random-effects model estimated standardized mean differences (SMD) and risk ratios. 11 studies (4064 participants) were analyzed, 8 focused on nAMD and 2 on DME. No significant differences in best-corrected visual acuity changes were observed between biosimilars and reference aflibercept in studies on nAMD (SMD = -0.04, 95 % confidence inerval [CI]: -0.15-0.06) or DME (SMD = 0.11, 95 % CI: -0.12-0.33). Central subfield thickness change at week 4 and the endpoint also showed no significant differences. Similarly, no significant differences were seen in choroidal neovacularization size, vision maintenance, anti-drug antibody development, treatment-emergent adverse events, or ocular adverse effects. Biosimilar aflibercept show similar efficacy and safety to the original for nAMD and DME, with no significant differences in key outcomes. They offer a cost-effective alternative that offers similar clinical benefits while improving treatment accessibility.