Stelara biosimilar confirms equivalence to original drug

[Courtesy of Samsung Bioepis]

South Korea’s Samsung Bioepis Co. announced Thursday that it has confirmed the equivalence of its biosimilar “SB17” to its reference product “Stelara,” in treating autoimmune diseases in a phase 3 clinical trial.

The company said that the results from the clinical trial were presented at the European Academy of Dermatology and Venereology (EADV) conference taking place in Berlin, Germany from Wednesday to Saturday (local time).

Stelara (ingredient name: ustekinumab) is a therapeutic drug developed by multinational pharmaceutical company Janssen to treat conditions including plaque psoriasis, psoriatic arthritis, and Crohn’s disease.

Samsung Bioepis completed a phase 3 clinical trial of SB17 on 503 patients with moderate to severe plaque psoriasis in eight countries worldwide, including Korea, in November 2022, and confirmed clinical and medical equivalence between the biosimilar and the original drug in terms of effectiveness and safety, the company said.

“The research results presented at the academic conference serve as an example of ongoing efforts to improve positive perceptions of biosimilars among doctors and patients,” according to Kim Hye-jin, vice president and medical and lifecycle safety team leader at Samsung Bioepis.

Samsung Bioepis signed a partnership agreement with Swiss pharmaceutical company Sandoz in September 2023 to commercialize SB17 in North America and Europe.