Sandoz announces exclusive deal to commercialize biosimilar ustekinumab, further reinforcing growing pipeline and immunology patient offering.
Sandoz, a global leader in generic and biosimilar medicines, announced that it has entered into a development and commercialization agreement with Samsung Bioepis
The agreement provides Sandoz with the exclusive rights to commercialize the biosimilar SB 17 ustekinumab in the US, Canada, EEA, Switzerland, and UK. Other specific terms of the agreement are confidential.
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.
The clinical development program for SB 17, 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 SB 17 matches reference ustekinumab in terms of pharmacokinetic (PK) bioequivalence, safety, tolerability, and immunogenicity.. SB 17 Phase III clinical study results will be presented at a medical congress later this year.
Patents on Stelara are set to expire in September 2023 in the United States and in January 2024 in most parts of Europe, with a number of biosimilars under development
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.