Samsung Bioepis commences clinical trial of its 10th biosimilar

[Photo provided by Samsung Bioepis Co.]

Samsung Bioepis Co. has initiated a Phase 1 clinical trial of SB17, a biosimilar version of Stelara (ustekinumab), which marks the 10th biosimilar pipeline of the Korean biopharmaceutical company.

A trial protocol was published on ClinicalTrials.gov on Feb. 26, the company said on Tuesday. The Phase 1 trial started in 201 healthy volunteers in France last month with an aim of demonstrating the drug’s pharmacokinetics, safety and immunogenicity.

The original drug of SB17, which is marketed by U.S. Johnson & Johnson (Janssen), is a prescription autoimmune disease medicine used to treat patients with psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. Stelara’s global sales came to $7.7 billion last year.

Founded in 2012 as a joint venture between Korean biopharmaceutical company Samsung Biologics under Samsung Group and its U.S. partner Biogen, Samsung Bioepis has successfully launched three autoimmune disease and two oncology biosimilars globally.

This is its 10th biosimilar’s clinical trial Samsung Bioepis, and additional therapeutic areas in the pipeline include eye diseases, blood diseases, and skeletal diseases, according to the company.

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