Samsung Bioepis Partners with Sandoz to Commercialize Ustekinumab Biosimilar Candidate

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  • Enters into a commercialization agreement for SB17, ustekinumab biosimilar candidate, in Europe and North America
  • Partnership to support Samsung Bioepis pipeline expansion and provide increased access to biosimilars

INCHEON, Korea, Sept. 11, 2023 (GLOBE NEWSWIRE) — Samsung Bioepis Co., Ltd. today announced that it has entered into a commercialization agreement with Sandoz for SB17, a proposed biosimilar to Stelarai (ustekinumab), marking a step forward in strengthening access to Samsung Bioepis’ immunology portfolio in the United States (US), Canada, European Economic Area (EEA), Switzerland and United Kingdom (UK).

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“This agreement is a testament to Samsung Bioepis’ strong track record in the field of immunology, demonstrating a potential value that our biosimilars could deliver for widening access to biologic medicines.” said Sang-Jin Pak, Executive Vice President and Head of Commercial Division, at Samsung Bioepis.

SB17, a proposed biosimilar to Stelara (ustekinumab), is Samsung Bioepis’ fourth candidate in its immunology pipeline, following SB4 (etanercept), SB2 (infliximab) and SB5 (adalimumab). Samsung Bioepis has a more than 5-year track record of supplying over 48 million units of immunology biosimilars in nearly 40 markets across the world.

In March, the company presented Phase 1 clinical study results of SB17 at the 2023 American Academy of Dermatology (AAD) Annual Meeting, which demonstrated pharmacokinetics (PK) equivalence and comparable safety, tolerability, immunogenicity profiles between SB17 and reference ustekinumab. SB17 Phase 3 clinical study results are set to be presented at a medical congress this year as Phase 3 study was completed in December 2022.

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About Samsung Bioepis Co., Ltd.

Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world’s leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology and endocrinology. For more information, please visit: www.samsungbioepis.com and follow us on social media – Twitter, LinkedIn.


i Stelara is a trademark of Janssen Pharmaceuticals.

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