INCHEON, Korea – March 17, 2023 – Samsung Bioepis Co., Ltd. today announced that SB17, a proposed biosimilar to Stelara¹ (ustekinumab), demonstrated pharmacokinetic (PK) bioequivalence and comparable safety, tolerability, and immunogenicity to reference ustekinumab in Phase 1 clinical study with healthy volunteers. These results will be presented at the 2023 American Academy of Dermatology (AAD) Annual Meeting held in New Orleans, Louisiana, from March 17 to 21, 2023.

In this Phase 1, randomized, double-blind, single-dose comparative pharmacokinetic study, a total of 201 subjects were randomized 1:1:1 to receive a single dose 45 mg of either SB17, EU-sourced reference ustekinumab, or US-sourced reference ustekinumab via subcutaneous injection. The primary objective of this study was to demonstrate PK similarity by assessing area under the concentration-time curve from time zero to infinity (AUCinf) and maximum serum concentration (Cmax). The secondary objectives were to investigate and compare the safety, tolerability, and immunogenicity between three treatment groups. 

For all comparisons of primary endpoints (AUCinf and Cmax) , the 90% confidence intervals (CIs) of the geometric least squares means (LSmeans) ratio were fully contained within the pre-defined equivalence margin of 0.80-1.25. Safety profiles and immunogenicity were also comparable among three treatment groups.

Details of the abstract are as follows:

• Abstract title: A Phase 1, Randomized, Double-Blind, Single-Dose Comparative Pharmacokinetic Study Comparing SB17
  (Proposed Ustekinumab Biosimilar) with Reference Ustekinumab in Healthy Subjects

• Abstract number: 41531

• Program type: ePoster 

• Presentation Date and time: March 18, 2023 16:15-16:20 (CST) 

• Authors: Hansol Jeong, Taeseung Kang, Jiyoon Lee, Seongsik Im

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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 biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, and endocrinology. For more information, please visit: www.samsungbioepis.com and follow us on social media – Twitter, LinkedIn.

Anna Nayun Kim, nayun86.kim@samsung.com

Jane Chung, ejane.chung@samsung.com

References: 

¹ Stelara is a trademark of Janssen Pharmaceuticals.