Samsung Bioepis to cooperate with Swiss firm Sandoz
Jeong Min Nam
Sep 11, 2023 (Gmt+09:00)
Samsung Bioepis headquarters Samsung Bioepis Co., a biopharmaceutical research and development unit under South Korea's Samsung Group, announced on Monday that it signed a partnership agreement with Swiss pharmaceutical company Sandoz for sales of autoimmune disease treatment Stelara (active ingredient: ustekinumab)’s biosimilar SB17 in North America and Europe.
Stelara is a therapeutic drug developed by the multinational pharmaceutical company Janssen for conditions such as plaque psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis. Samsung Bioepis, following biosimilars for Enbrel, Remicade and Humira, has been developing SB17 as its fourth immunology biosimilar and is currently undergoing global regulatory approval processes.
In March this year, Samsung Bioepis disclosed the results of its Phase 1 clinical study, confirming the equivalence in pharmacokinetics, safety and immunogenicity through comparative research between SB17 and the original drug at the American Academy of Dermatology (AAD) annual conference.
The Phase 3 clinical trial for SB17 was completed in Dec. last year, and the results are scheduled to be presented at relevant academic conferences later this year.
"Through this partnership, our company has once again affirmed its capabilities in the autoimmune disease treatment market, and we are now in a stronger position to solidify the value of biosimilars in terms of expanding patient access," said Park Sang-jin, Head of Commercial Division at Samsung Bioepis.