Samsung Bioepis Co., Ltd. has signed a settlement and license agreement with Johnson & Johnson settling all pending US patent litigation between the two companies and clearing the way for commercialization of Samsung Bioepis’ SB17, a proposed biosimilar of reference medicine Stelara® (ustekinumab) in the United States (US). In the US, the license period will begin on February 22, 2025. The other terms of the agreement are confidential.
Ustekinumab is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody that prevents abnormal regulation of IL-12 and IL-23 associated with immune-mediated diseases. Stelara® is approved for treatment of moderate-to-severe plaque psoriasis, Crohn’s disease, ulcerative colitis and active psoriatic arthritis.1 SB17, developed by Samsung Bioepis, is a proposed biosimilar to reference medicine Stelara®.
The Biologics License Application (BLA) for SB17 is under review by the FDA. SB17, if approved, will be commercialized in the US by Sandoz.
Samsung Bioepis and Sandoz have entered into a development and commercialization agreement for SB17 in September 2023 for the US, Canada, European Economic Area (EEA), Switzerland and United Kingdom (UK).
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