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Samsung Bioepis Initiates Phase 1 Clinical Trial for SB35, A Biosimilar Candidate Referencing Taltz (Ixekizumab)
INCHEON, Korea – August 28, 2026 – 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, please visit www.samsungbioepis.com and follow us on LinkedIn and X.
MEDIA CONTACT
Anna Nayun Kim, nayun86.kim@samsung.com
Yoon Kim, yoon1.kim@samsung.com
1 Taltz is a trademark of Eli Lilly.
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
