FEB 01, 2021
A new phase 3 equivalence study tested the safety and efficacy of the proposed ranibizumab biosimilar SB11.
This multicenter, randomized, double-masked, parallel-group study compared intravitreous injection of SB11 with ranibizumab (0.5 mg) dosed every 4 weeks through week 48. The study cohort consisted of 705 participants aged 50 years or older diagnosed with neovascular AMD with active subfoveal choroidal neovascularization lesions.
At week 4, central subfield thickness decreased by 108 μm in the SB11 group compared with 100 μm in the ranibizumab group. By week 8, the change in BCVA from baseline was 6.2 letters in the SB11 group and 7 letters in the ranibizumab group. Incidences of treatment-emergent adverse events—including serious events and those leading to study drug discontinuation—were similar in both groups.
The primary shortcoming of this study is the relatively short reporting window (24 weeks). Data from longer studies are required to demonstrate continued similarities in efficacy and safety.
This study showed similar short-term efficacy and safety between SB11 and ranibizumab for neovascular AMD, contributing to the evidence supporting biosimilarity.