Samsung Bioepis Initiates Phase 1 Clinical Trial for SB17, Proposed Biosimilar to Stelara (Ustekinumab)
- Category: Antibodies
- Published on Monday, 01 March 2021 11:02
- Hits: 1137
INCHEON, Korea I March 01, 2021 I Samsung Bioepis Co., Ltd. today announced the initiation of Phase 1 clinical trial for SB17, the company's proposed biosimilar referencing Stelara (ustekinumab). The Phase 1 clinical trial for SB17 (ustekinumab) is a randomized, double-blind, three-arm, parallel group, single-dose study to compare the pharmacokinetics (PK), safety, tolerability, and immunogenicity of Stelara and SB17 in healthy male volunteers. More information on this study is available at clinicaltrials.gov (NCT#04772274).
As of March 2021, Samsung Bioepis has four biosimilar candidates in clinical development – SB12 (eculizumab), SB15 (aflibercept), and SB16 (denosumab) in Phase 3 clinical trial and SB17 (ustekinumab) in Phase 1 clinical trial.
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 biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology and hematology. Samsung Bioepis is a joint venture between Samsung Biologics and Biogen. For more information, please visit: www.samsungbioepis.com and follow us on social media– Twitter, LinkedIn.
SOURCE: Samsung Bioepis