Samsung Bioepis Secures U.S. License Date for Stelara® Biosimilar SB17 Following Settlement with Johnson & Johnson

On November 30, Samsung Bioepis Co., Ltd. and Johnson & Johnson entered into a settlement and license agreement, resolving all pending U.S. patent litigations between the two companies.Paves the Way for the Commercialization of Proposed Biosimilar Stelara® (ustekinumab) in the U.S.

In the United States, the licensing period will commence on February 22, 2025. Other terms of the agreement remain confidential.

Kris Soyoung Lee, Vice President and Head of the Commercial Team at Samsung Bioepis, stated: "We welcome this agreement, which will potentially expand treatment options for patients with inflammatory diseases through the commercialization of Samsung Bioepis' SB17 biosimilar in the United States."”

She added: "Through ourIn ProductContinuous innovation in development and a steadfast commitment to quality will drive us to further advance and expand our...Our biosimilar investment portfolio, so that more patients and healthcare systems around the world can benefit from biosimilars.”

Ustekinumab is a human immunoglobulin G1κ (IgG1κ) monoclonal antibody that prevents the abnormal regulation of IL-12 and IL-23 associated with immune-mediated diseases.SB17 is a Stelara® biosimilar developed by Samsung Bioepis.

Stelara® has been approved for the treatment of moderate to severe plaque psoriasis, Crohn's disease, ulcerative colitis, and active psoriatic arthritis.

The Biologics License Application (BLA) for SB17 is under review by the U.S. Food and Drug Administration.If approved, SB17 will beSandoz CompanySold in the United States.

Samsung Bioepis and Sandoz reached a development and commercialization agreement for SB17 in the United States, Canada, the European Economic Area (EEA), Switzerland, and the United Kingdom in September 2023.