Blog Big Molecule Watch March 02, 2021

Samsung Bioepis Initiates Phase 1 Trial of Ustekinumab Biosimilar

Earlier today, Samsung Bioepis announced the initiation of a Phase 1 clinical trial for SB17, the company’s proposed biosimilar to Stelara® (ustekinumab).  The trial will compare the pharmacokinetics, safety, tolerability, and immunogenicity of SB17 and Stelara®.  With the start of this trial, Samsung Bioepis has the following biosimilar candidates in clinical development:  SB12 (eculizumab), SB15 (aflibercept) and SB16 (denosumab) in Phase 3 clinical trials, and SB17 (ustekinumab) in a Phase 1 clinical trial.

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