The partnership with Samsung Bioepis Grants Novartis’ generic-drugs unit Sandoz exclusive commercialization rights for biosimilar SB17 Ustekinumab in Europe and North America.
Ustekinumab, a fully human monoclonal antibody targeting interleukin (IL)-12/23, is approved for the treatment of plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis.
This strategic deal further solidifies Sandoz’s presence in the field of immunology and provides valuable support for the expansion of its product pipeline.
Sandoz, a prominent global player in generic and biosimilar pharmaceuticals, announced today a collaborative development and commercialization agreement with Samsung Bioepis.
Under this agreement, Sandoz gains exclusive rights for the commercialization of the biosimilar SB17 ustekinumab in the United States, Canada, the European Economic Area (EEA), Switzerland, and the United Kingdom. The specific terms of the agreement remain confidential.
Richard Saynor, CEO of Sandoz, commented:
“This deal represents another major step to reinforce our high-value biosimilar pipeline, in line with our plans to become a standalone global leader. 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 drug, Stelara (ustekinumab), is a monoclonal antibody designed to target interleukin (IL)-12/23 and is used to treat autoimmune conditions such as Crohn’s disease, plaque psoriasis, psoriatic arthritis, and ulcerative colitis.
Psoriasis, a chronic inflammatory skin disorder, affects approximately 60 million individuals worldwide. Psoriasis significantly impacts patients’ quality of life (QoL) and imposes a substantial economic burden, with an average annual cost of up to EUR 11,928 per patient globally.
Inflammatory bowel diseases (Crohn’s disease and ulcerative colitis) are persistent gastrointestinal disorders affecting more than 3 million people in Europe and the US. These conditions carry a substantial economic cost, with direct annual expenses reaching up to 6 billion EUR in Europe and 25.4 billion USD in the USA. Inflammatory bowel diseases negatively affect patients’ daily activities, work capacity, and social interactions.
The clinical development program for SB17, a ustekinumab biosimilar, is well advanced, with Phase I results presented at the American Academy of Dermatology (AAD) Annual Meeting in New Orleans, US, in March 2023 by Samsung Bioepis. These results demonstrated that SB17 is pharmacokinetically (PK) bioequivalent to the reference ustekinumab, exhibiting comparable safety, tolerability, and immunogenicity. Phase III clinical study findings for SB17 are scheduled for presentation at a medical conference later this year.
For more information, please visit: https://novartis.com
Original Source: Press Release, September 11, 2023 01:15 ET| Source: Novartis Pharma AG, GlobeNewswire: https://www.globenewswire.com/news-release/2023/09/11/2740467/0/en/Sandoz-announces-exclusive-deal-to-commercialize-biosimilar-ustekinumab-further-reinforcing-growing-pipeline-and-immunology-patient-offering.html