Biosimilar News: Samsung Bioepis Secures US License Date for Proposed Stelara Biosimilar


The license period will begin on February 22, 2025 in the US.

Samsung Bioepis Co., Ltd. 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 US. 

In the US, the license period will begin on February 22, 2025. The other terms of the agreement are confidential.

“We welcome this agreement which clears the way for SB17 in the US, which has a potential to broaden access to treatment for patients suffering inflammatory conditions,” says Kris Soyoung Lee, Vice President and Commercial Team Leader, at Samsung Bioepis, in a news release. “Through our continuous innovations in product development and an uncompromising commitment to quality, we remain dedicated to advancing and expanding our biosimilar portfolio, so that more patients and healthcare systems across the world may benefit from biosimilars,” she added.

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.   The Biologics License Application (BLA) for SB17 is under review by the U.S. Food and Drug Administration. 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.

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