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

Samsung Bioepis Co., Ltd. announced today the initiation of Phase 1 clinical trial for SB35, a biosimilar candidate referencing Taltz (ixekizumab)¹.

The Phase 1 clinical trial for SB35 is a randomized, double-blind, two-arm, parallel group, single-dose study to compare the pharmacokinetics, safety, tolerability, and immunogenicity of SB35 to Taltz in healthy participants. Participants will be randomized 1:1 to receive a single dose of either SB35 or Taltz. Primary outcome measures are AUCinf (area under the concentration-time curve from time zero to infinity), Cmax (maximum serum concentration), and AUClast (area under the concentration-time curve from time zero to the last quantifiable concentration) from Day 1 to Day 85. More information on this study is available at clinicaltrials.gov (NCT07789964).

Ixekizumab is a humanized IgG4 monoclonal antibody that works by selectively binding to the pro-inflammatory cytokine interleukin-17A (IL-17A) and blocking its interaction with the IL-17 receptor, which stops the signaling cascade that causes chronic inflammation in conditions like plaque psoriasis, psoriatic arthritis, axial spondyloarthritis and enthesitis-related arthritis.²

About Samsung Bioepis Co., Ltd.
Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biologic candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, neurology, and endocrinology. For more information, visit www.samsungbioepis.com

¹ Taltz is a trademark of Eli Lilly.

² European Medicines Agency. (2026). Taltz: Summary of Product Characteristics. Retrieved from https://www.ema.europa.eu/en/medicines/human/EPAR/taltz