Evaluating the Efficacy and Safety of Aflibercept Biosimilar (P041) Compared with Originator Product in Patients with Neovascular Age-Related Macular Degeneration

To assess the non-inferiority of biosimilar aflibercept (CinnaGen Company, Iran) (P041) to the originator aflibercept (Regeneron, US) (AFL) in terms of efficacy, safety, and immunogenicity. This was a phase Ш, 52-week, multicenter, randomized, double-masked, and active control trial involving eyes in a 1:1 ratio. Patients with active subfoveal choroidal neovascularization secondary to age-related macular degeneration randomized into the two groups of P041 and AFL. Patients received an injection of aflibercept every 4 weeks for 3 doses, followed by administration every 8 weeks up to week 48. The primary outcome was the non-inferiority analysis of eyes maintaining vision at week 52. Secondary outcomes included the changes in visual acuity (VA) and retinal thickness, safety evaluation, and immunogenicity during the study. In total, 168 eyes of 168 patients were included. At week 52, the proportion of patients maintaining vision was 94.44% in P041 compared to 94.52% in AFL group. The 95% confidence interval (CI) for the difference of maintaining vision from baseline did not exceed the predefined non-inferiority margin of 10% (p-value: 0.98, 95% CI, -0.0008 (-0.074, 0.074)). Secondary outcomes indicated similar results in both arms (all p-values >0.05). Safety measured outcomes and immunogenicity were similar between the two study groups. P041 was noninferior to AFL in eyes with n-AMD. Other efficacy and safety findings also indicated the similarity of two products.