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Samsung Bioepis Presents Two Abstracts for SB17, a Proposed Biosimilar to Stelara (Ustekinumab), at the 19th Annual Congress of European Crohn’s and Colitis Organisation (ECCO)
• Analytical characterization and similarity assessment results also demonstrate SB17 is highly similar to reference ustekinumab in terms of structural, physicochemical and biological attributes
• Totality of evidence based on analytical, non-clinical, and clinical data for SB17 supports extrapolation to reference ustekinumab
INCHEON, Korea – February 22, 2024 – Samsung Bioepis Co., Ltd. today announced that two new study results for SB17, a proposed biosimilar to Stelara1 (ustekinumab),will be presented at the 19th Congress of European Crohn’s and Colitis Organisation (ECCO) being held from February 21 to 24 in Stockholm, Sweden.
Of the two studies, one study provided an overview of analytical assessment results of SB17 compared to reference ustekinumab. Overall analytical characterization and similarity assessment results demonstrated SB17 is highly similar to the Europe and U.S. reference ustekinumab in terms of structural, physicochemical and biological attributes.
In addition, the “totality-of-the evidence” data supported the extrapolation of SB17 to reference ustekinumab. With biosimilarity in pharmacodynamics, pharmacokinetics (PK) and clinical effect for moderate-to-severe psoriasis (PsO) patients, SB17 is considered to be highly similar to reference ustekinumab in physicochemical, non-clinical, and clinical studies.
“The presentations we studied show our ongoing commitment to providing clinically proven biosimilars in terms of efficacy, and safety to patients who need them and making physicians and patients confident on use of biosimilar across indications,” said Hyejin Kim, Vice President, Medical and Lifecycle Safety Team Leader at Samsung Bioepis.
SB17 is Samsung Bioepis’ fourth candidate in immunology pipeline. In September 2023, the company announced a partnership with Sandoz to commercialize SB17 in the United States (US), Canada, European Economic Area (EEA), Switzerland and United Kingdom (UK).
Details of the Samsung Bioepis’ abstracts are as follows:
Presentation Title | Presentation Details |
Characterization for the Similarity Assessment Between Proposed Biosimilar SB17 and Ustekinumab Reference Product Using State-of-the-art Analytical Method | Session: Guided Poster Session Date/Time: Feb 23/ 12:40 - 13:40 Abstract Number: P134 Authors: Sung-Yong Yang, Changsoo Lee, Keumbi Hwang, Jungmin Lee, JaeIl Lee, Jooyong Hong, Seongyoung Jung |
"Totality-of-the-evidence” of proposed ustekinumab biosimilar SB17 | Session: Guided Poster Session Date/Time: Feb 23/ 12:40 - 13:40 Abstract Number: P1019 Authors: Alessandro Armuzzi, Giampiero Girolomoni, Steven Feldman, Joao Goncalves, Younjin Park, Byong Duk Ye |
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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 – X (Twitter), LinkedIn.
1 Stelara is a trademark of Johnson & Johnson.
1 Stelara is a trademark of Johnson & Johnson.
