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Samsung Bioepis Begins P-I Trial of SB35 (Biosimilar, Taltz)

Shots: 

  • Samsung Bioepis Initiates Phase 1 Trial of SB35 (ixekizumab), a Biosimilar version of Taltz  
  • The P-I randomized, double-blind study will compare single-dose SB35 and Taltz in healthy participants for PK, safety, tolerability, and immunogenicity. Participants will be randomized 1:1, with 1EP including AUCinf, Cmax, and AUClast through Day 85 
  • Ixekizumab is a humanized IgG4 mAb that selectively binds to IL-17A, blocking IL-17 receptor signaling and reducing chronic inflammation associated with plaque psoriasis, psoriatic arthritis, axial spondyloarthritis, and enthesitis-related arthritis. 

Ref: Samsung Bioepis | Image: Samsung Bioepis Press Release

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