Samsung Bioepis, Organon announces results from study of SB5

Samsung Bioepis and Organon announced topline results from the interchangeability study for SB5, a biosimilar to Humira. The Phase 4, randomized, double-blind, parallel-group, multiple-dose, active comparator, multicenter clinical study for SB5 was conducted across 33 sites in four countries from August 2022 to May 2023 in patients with moderate to severe chronic plaque psoriasis. The primary objective of the study was to assess the pharmacokinetic similarity between two treatment groups: patients with moderate to severe plaque psoriasis who switched multiple times between Humira and high-concentration SB5 versus patients receiving ADL continuously. All 371 patients who were enrolled in the study had no prior treatment with ADL and were treated in this study with ADL during a lead-in period of 13 weeks. At Week 13, patients who achieved at least a 50% reduction in Psoriasis Area and Severity Index response were randomized in a 1:1 ratio to either be switched between ADL and SB5 or continue on ADL. The study achieved all primary endpoints. Efficacy profiles, safety profiles, and immunogenicity were also comparable between two treatment groups.