Samsung Bioepis Receives US License Date for Proposed Ustekinumab Biosimilar, SB17

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Samsung Bioepis announced today that it has signed a settlement and license agreement with Johnson & Johnson to settle all pending US patent litigations between both companies. The license agreement allows for the commercialization of Samsung Bioepis’ SB17, a proposed biosimilar to ustekinumab Stelara) in the US. The US license period will start on February 22, 2025. Other terms of the agreement are confidential, according to the announcement.

The Biologics License Application for SB17 is under review by the US Food and Drug Administration (FDA). If SB17 is approved, it will be commercialized in the US by Sandoz, a Novartis division. Samsung Bioepis and Sandoz entered into a development and commercialization agreement for SB17 in September 2023 for the US, Canada, the European Economic Area, Switzerland, and the United Kingdom.

In March 2023, Sandoz received FDA approval of another biosimilar to adalimumab (Humira; AbbVie), Hyrimoz, a citrate-free high-concentration formulation of adalimumab-adaz.

Vice president and commercial team leader of Samsung Bioepis, Kris Soyoung Lee, is looking forward to the potential approval of SB17 in the US. “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. 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,” said Lee in the news release.

Ustekinumab is a human immunoglobulin G1 kappa monoclonal antibody that prevents abnormal regulation of IL-12 and IL-23 associated with immune-mediated diseases. Ustekinumab is approved for the treatment of moderate to severe plaque psoriasis, Crohn’s disease, ulcerative colitis, and active psoriatic arthritis.

Reference

Samsung Bioepis secures US license data for SB17, a proposed biosimilar to Stelara. News release. BioSpace. November 30, 2023. Accessed November 30, 2023. https://www.biospace.com/article/releases/samsung-bioepis-secures-us-license-date-for-sb17-a-proposed-biosimilar-to-stelara-/#:~:text=INCHEON%2C%20Korea%2C%20Nov.%2030,a%20proposed%20biosimilar%20of%20reference