Sandoz gets exclusive rights to commercialize biosimilar SB17 ustekinumab in US, Canada, EEA, Switzerland and UK

“This deal represents another major step to reinforce our high-value biosimilar pipeline, in line with our plans to become a standalone global leader,” says Sandoz CEO Richard Saynor. “It will further strengthen our immunology patient offering and means we now have five potential high-value upcoming biosimilar launches over the next few years.”

The reference medicine Stelara (ustekinumab) is a monoclonal antibody medication to interleukin (IL)-12/23 for the treatment of autoimmune disorders including Crohn's disease, plaque psoriasis, psoriatic arthritis, and ulcerative colitis.

Psoriasis is a chronic inflammatory disease of the skin and other parts of the body, which affects 60 million people worldwide. Psoriasis has a huge impact on patients´ quality of life (QoL) and has a substantial economic burden, with annual mean costs of up to EUR 11,928 per patient globally. Inflammatory bowel diseases (Crohn´s disease and ulcerative colitis) are chronic gastrointestinal disorders that affect more than 3 million people in Europe and in the US, with a high associated economic burden and annual direct costs of up to 6 bn in Europe and 25.4 bn USD in the USA. IBD negatively impacts patients’ quality of life by affecting daily activities, work ability and social life.

The clinical development program for SB17, a ustekinumab biosimilar, is well advanced and Phase I results were presented at the American Academy of Dermatology (AAD) Annual Meeting held in New Orleans, US, in March 2023 by Samsung Bioepis. This study demonstrated that SB17 matches reference ustekinumab in terms of pharmacokinetic (PK) bioequivalence, safety, tolerability, and immunogenicity. SB17 Phase III clinical study results will be presented at a medical congress later this year.