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Samsung Bioepis begins late stage clinical trial of ustekinumab biosimilar

A picture shows Samsung Bioepis corporate logo (Samsung Bioepis)
A picture shows Samsung Bioepis corporate logo (Samsung Bioepis)

Samsung Bioepis said Tuesday that the company has started a Phase 3 clinical trial for its ustekinumab biosimilar candidate, SB17.

SB17 is the the South Korean biopharmaceutical company’s 10th biosimilar pipeline. The reference ustekinumab product is Stelara, a prescription medicine developed by Johnson & Johnson’s pharmaceutical unit Janssen, used to treat patients with plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis.

First approved in 2009, Stelara is Johnson & Johnson’s top selling drug, which generated $7.7 billion in revenue for the company last year. The drug, however, could see the end of US patent protection in 2023.

Samsung Bioepis’ upcoming clinical trial will evaluate SB17 in patients with moderate-to-severe plaque psoriasis. The company added it would evaluate the safety, efficacy and immunogenicity of SB17 in comparison with Stelara.

The phase 3 clinical trial will involve 464 patients from eight countries around the globe, including, Poland and the Czech Republic, according to Samsung Bioepis.

“Samsung Bioepis will accelerate development of SB17 to help improve patient access to the treatment,” an official from the company said.

To date, Samsung Bioepis has successfully launched three autoimmune disease and two oncology biosimilars globally.

By Shim Woo-hyun (