Samsung Bioepis Initiates Phase 1 Clinical Trial for SB35, A Biosimilar Candidate Referencing Taltz (Ixekizumab)

Samsung Bioepis has launched a Phase 1 clinical trial for SB35, a biosimilar to Taltz (ixekizumab), on August 28. This study aims to compare the pharmacokinetics, safety, tolerability, and immunogenicity of SB35 to Taltz in healthy participants. The trial is a randomized, double-blind, two-arm, parallel group, single-dose study where participants will receive a single dose of either SB35 or Taltz, with a 1:1 ratio.

The primary outcomes are AUCinf, Cmax, and AUClast from Day 1 to Day 85. Further details can be found on clinicaltrials.gov (NCT07789964). Ixekizumab, the reference drug, is a humanized IgG4 monoclonal antibody that targets the pro-inflammatory cytokine interleukin-17A (IL-17A), inhibiting its interaction with the IL-17 receptor and preventing the inflammatory cascade associated with various arthritis conditions.