A post hoc analysis of phase 3 trial data showed no association of immunogenicity with efficacy or safety for both ranibizumab and the biosimilar SB11 in patients with neovascular age-related macular degeneration.
In addition, a low incidence of antidrug antibodies was found with both drugs.
Byooviz (SB11, ranibizumab-nuna, Samsung Bioepis) was approved by the European Medicines Agency and the FDA in 2021 following a head-to-head phase 3 trial that demonstrated equivalent efficacy to the originator biologic Lucentis (ranibizumab, Genentech). In the current analysis, the association of