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

Abstract

ObjectiveTo 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. DesignThis was a phase Ш, 52-week, multicenter, randomized, double-masked, and active control trial involving eyes in a 1:1 ratio. SubjectsPatients with active subfoveal choroidal neovascularization secondary to age-related macular degeneration randomized into the two groups of P041 and AFL. Methods and InterventionsPatients received an injection of aflibercept every 4 weeks for 3 doses, followed by administration every 8 weeks up to week 48. Main Outcome MeasuresThe 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. ResultsIn 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. ConclusionP041 was noninferior to AFL in eyes with n-AMD. Other efficacy and safety findings also indicated the similarity of two products.