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

OBJECTIVE: 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.

DESIGN: This was a phase Ш, 52-week, multicenter, randomized, double-masked, and active control trial involving eyes in a 1:1 ratio.

SUBJECTS: Patients with active subfoveal choroidal neovascularization secondary to age-related macular degeneration randomized into the two groups of P041 and AFL.

METHODS AND INTERVENTIONS: Patients received an injection of aflibercept every 4 weeks for 3 doses, followed by administration every 8 weeks up to week 48.

MAIN OUTCOME MEASURES: 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.

RESULTS: 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.

CONCLUSION: P041 was noninferior to AFL in eyes with n-AMD. Other efficacy and safety findings also indicated the similarity of two products.