Samsung Bioepis said Tuesday that it has entered phase 3 clinical trials of SB17, a biosimilar drug of Stelara (ingredient: ustekinumab), for treating patients with moderate to severe plaque psoriasis.

The company began its multinational study in eight countries, including  Korea, Poland, and the Czech Republic, to evaluate the efficacy, safety, tolerability, pharmacokinetics, and immunogenicity of SB17 compared to the original in July.

The original biologic of SB17, ustekinumab, was developed by Janssen Pharmaceuticals to treat autoimmune diseases, such as psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.

Samsung Bioepis said the drug’s global sales reached 8.4 trillion won ($7.29 billion) in 2020. 

The company stressed that it would speed up developing SB17 as the company began the phase 3 study with 464 patients in addition to the phase 1 trial that has been going on in France with 201 healthy adults since February.

People with plaque psoriasis have thick, pink or red patches of skin covered with white or silvery scales, and 80 to 90 percent of psoriasis patients suffer from the plaque.

"We will accelerate the development of SB17 and other biosimilars of medicines marketed in Europe and elsewhere to provide more therapeutic access to patients with various autoimmune diseases around the world," a Samsung Bioepis official said.

The official added that the company has expanded the pipelines for autoimmune diseases with the phase 3 clinical trials of SB17. It now has four follow-up biosimilars under development in phase 3 studies.