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Sandoz inks deal with Samsung Bioepis to commercialize Stelara biosimilar

Ustekinumab is a fully human monoclonal antibody to interleukin (IL)-12/23, approved for treatment of plaque psoriasis, psoriatic arthritis, Crohn´s disease and ulcerative colitis.
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Sandoz has entered into a development and commercialization agreement with Samsung Bioepis.

The agreement provides Sandoz with the exclusive rights to commercialize the biosimilar SB17 ustekinumab in the U.S., Canada, EEA, Switzerland and the U.K. 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.

[Read more: AAM report: Generics, biosimilars generated $373B savings in 2021]

“This deal represents another major step to reinforce our high-value biosimilar pipeline, in line with our plans to become a standalone global leader,” said Richard Saynor, CEO of Sandoz. “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.” 

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 and has a substantial economic burden, the company said.

[Read more: Novartis spin-off of Sandoz generics drug unit to occur on or around Oct. 4]

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 United States, with a high associated economic burden and annual direct costs of up to $6 billion in Europe and $5.4 billion in the United States. IBD negatively impacts patients’ quality of life by affecting daily activities, work ability and social life, the company said.

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