SB17, the proposed biosimilar to Stelara1 (ustekinumab), has proved its mettle in a Phase 1 clinical study with healthy volunteers. It demonstrated pharmacokinetic (PK) bioequivalence and comparable safety, tolerability, and immunogenicity to the reference ustekinumab.
In recognition of this, the results will be presented at the 2023 American Academy of Dermatology (AAD) Annual Meeting in New Orleans, Louisiana, from March 17 to 21, 2023. This milestone achievement is a testament to the power of biosimilars, underscoring their potential to revolutionize patient access to life-saving treatments.
This Phase 1, randomized, double-blind, single-dose comparative pharmacokinetic study investigated the safety, tolerability, and immunogenicity of SB17, EU-sourced reference ustekinumab, and US-sourced reference ustekinumab.
A total of 201 subjects were given a single 45 mg subcutaneous injection of one of the three treatments and the primary objective was to assess their pharmacokinetic similarity by measuring area under the concentration-time curve from time zero to infinity (AUCinf) and maximum serum concentration (Cmax).
The results of the comparison of primary endpoints such as AUCinf and Cmax demonstrated that the 90% confidence intervals of the geometric least squares means ratio were within the pre-defined equivalence margin of 0.80-1.25. Furthermore, safety profiles and immunogenicity were consistent across all three treatment groups. These findings suggest that the treatments are equally effective, safe, and immunogenic.
About Samsung Bioepis Co., Ltd.
Since its inception in 2012, Samsung Bioepis has been on a mission to make healthcare accessible to everyone. Through its cutting-edge product development and uncompromising commitment to quality, the biopharmaceutical company is well on its way to becoming a leader in the industry.
Samsung Bioepis has a diverse pipeline of biosimilar candidates that span multiple therapeutic areas, such as immunology, oncology, ophthalmology, hematology, and endocrinology. With its pioneering spirit and unwavering dedication, Samsung Bioepis is sure to make a lasting impact in the world of biopharmaceuticals.