{
  "id": 3975819,
  "title": "Samsung Bioepis Initiates Phase 1 Clinical Trial for SB35, A Biosimilar Candidate Referencing Taltz (Ixekizumab)",
  "url": "https://urgent.news/2026/08/28/samsung-bioepis-initiates-phase-1-clinical-trial-for-sb35-a",
  "topic": "health",
  "section": "Health & Medicine",
  "published": "2026-08-28T14:20:16.000Z",
  "source": {
    "name": "BusinessKorea",
    "slug": "businesskorea",
    "url": "https://www.businesskorea.co.kr/news/articleView.html?idxno=275787"
  },
  "original_language": "en",
  "account": "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.",
  "summary": "Samsung Bioepis Co., Ltd. announced on Aug. 28 the initiation of Phase 1 clinical trial for SB35, a biosimilar candidate referencing Taltz (ixekizumab).The Phase 1 clinical trial for SB35 is a randomized, double-blind, two-arm, parallel group, single-dose study to compare the pharmacokinetics, safet",
  "key_points": [
    "Samsung Bioepis begins Phase 1 trial for SB35 biosimilar on August 28",
    "Study compares pharmacokinetics, safety, tolerability, immunogenicity of SB35 vs Taltz",
    "Primary outcomes measured: AUCinf, Cmax, AUClast from Day 1 to Day 85"
  ],
  "editors_take": null,
  "illustration": null,
  "coverage": {
    "outlets": 1,
    "also_reported_by": []
  },
  "ai_generated": true,
  "disclaimer": "Summaries, key points and the editor’s take are written by software from other outlets’ reporting and may contain errors — always check the linked original."
}