Sandoz Enters into an Agreement with Samsung Bioepis To commercialise Biosimilar Ustekinumab

Sandoz, a major producer in generic and biosimilar pharmaceuticals, has signed a development and commercialization cooperation with Samsung Bioepis. According to the company's statement, the deal grants Sandoz exclusive rights to commercialize the biosimilar SB17 ustekinumab in the United States, Canada, the European Union, Switzerland, and the United Kingdom.

Other precise conditions of the arrangement are kept private. The standard medication Stelara (ustekinumab) is an interleukin (IL)-12/23 monoclonal antibody drug used to treat autoimmune illnesses such as Crohn's disease, plaque psoriasis, psoriatic arthritis, and ulcerative colitis. Psoriasis is a chronic inflammatory skin and other body condition that affects 60 million individuals worldwide. Psoriasis has a significant influence on patients' quality of life (QoL) as well as a significant economic burden, with yearly mean costs of up to EUR 11,928 per patient worldwide.

Inflammatory bowel illnesses (Crohn's disease and ulcerative colitis) are chronic gastrointestinal disorders that afflict over 3 million people in Europe and the United States3, with a significant economic burden and annual direct expenses of up to 6 billion euros in Europe4 and 25.4 billion dollars in the United States. IBD reduces patients' quality of life by interfering with everyday activities, employment ability, and interactions with others. The clinical development program for SB17, a ustekinumab biosimilar, is well underway, and Samsung Bioepis reported Phase I data at the American Academy of Dermatology (AAD) Annual Meeting in New Orleans, US, in March 2023. SB17 matches reference ustekinumab in terms of pharmacokinetic (PK) bioequivalence, safety, tolerability, and immunogenicity, according to this study. The results of the SB17 Phase III clinical study will be presented at a medical symposium later this year, according to the company.