• Phase 3 study for SB17, Samsung Bioepis’ ustekinumab biosimilar candidate, demonstrates biosimilarity with reference ustekinumab through equivalent efficacy and comparable safety and pharmacokinetics (PK) up to Week 28
• Also presents 4-year follow-up data of efficacy and safety of adalimumab biosimilar SB5 in patients with moderate to severe psoriasis from British Association of Dermatologics and Immunomodulators Register (BADBIR)
INCHEON, Korea – October 11 2023 – Samsung Bioepis Co., Ltd.’s new data on its ustekinumab biosimilar candidate SB17 and four-year follow-up data for its adalimumab biosimilar SB5 are presented today at the European Academy of Dermatology and Venereology (EADV) Congress being held from October 11 to 14 in Berlin, Germany.
The Phase 3 study for SB17, a proposed biosimilar to Stelara1 (ustekinumab), was a randomized double-blind study to compare efficacy, safety, pharmacokinetics (PK), and immunogenicity of SB17 with reference ustekinumab (UST) in patients with moderate to severe plaque psoriasis. The study demonstrated biosimilarity of SB17 to UST through equivalent efficacy and comparable safety and PK up to Week 28.
The study met the primary endpoint - percent change from baseline in Psoriasis Area Severity Index (PASI) at Week 12, with an adjusted difference of -0.6 (95% confidence interval (CI): [−3.780 to 2.579], per-protocol set), being fully contained within the pre-defined equivalence margin. Other efficacy and safety endpoints were comparable up to Week 28.
SB17 is Samsung Bioepis’ fourth candidate in immunology pipeline, following SB4 (etanercept), SB2 (infliximab) and SB5 (adalimumab). In September, the company announced a partnership deal with Sandoz to commercialize SB17 in the United States (US), Canada, European Economic Area (EEA), Switzerland and United Kingdom (UK).
Samsung Bioepis also shared 4-year follow-up data of effectiveness and safety of its adalimumab biosimilar SB5 in patients with moderate to severe psoriasis from the British Association of Dermatologists Biologics and Immunomodulators Register (BADBIR) - a UK and Ireland registry that assesses the long-term safety of biologic treatments for psoriasis, in which Samsung Bioepis has participated since May 2016. The 4-year follow-up data of eligible patients treated with SB5 between June 2019 and August 2022 from BADBIR indicated that SB5 can be started or transitioned from reference adalimumab in patients with moderate-to-severe psoriasis with an effectiveness and safety profile.
“Presenting two abstracts at EADV demonstrates our continuous commitment to providing clinically proven biosimilars in terms of efficacy, safety and immunogenicity to patients who need them and making physicians and patients confident on use of biosimilar in real setting,” said Hyejin Kim, Vice President, Medical and Lifecycle Safety Team Leader at Samsung Bioepis.
SB5 was approved by the European Commission (EC) in August 2017, under the brand name IMRALDI™ as a biosimilar to HUMIRA2. In Europe, IMRALDI™ is commercialized by Biogen along with BENEPALI™ (etanercept; SB4) and FLIXABI™ (infliximab; SB2). Samsung Bioepis’ and Biogen’s anti-TNF treatment products have helped nearly 256,0003 patients in Europe.
Details of the Samsung Bioepis’ abstracts are as follows:
A Randomised, Double-blind, Phase III Study Demonstrating Clinical Similarity of SB17 (Proposed Ustekinumab Biosimilar) to Reference Ustekinumab in Patients with Moderate to Severe Plaque Psoriasis
Abstract ID: 1320
Poster ID: P0720
Poster Open Date/Time: Oct 11, 9:00 AM
Authors: Steven Feldman, Joanna Narbutt, Giampiero Girolomoni, Jan Brzezicki, Nataliya Reznichenko, Maria Agnieszka Zegadlo-Mylik, Grazyna Pulka, Magdalena Dmowska-Stecewicz, Elżbieta Kłujszo, Dmytro Rekalov, Lidia Rajzer, Jiyoon Lee, Minkyung Lee, and Young Hee Rho
Long-Term Real-World Data of SB5 (Adalimumab Biosimilar) Treatment in Patients with Moderate-to-Severe Psoriasis from the British Association of Dermatologists Biologic and Immunomodulators Register (BADBIR))
Abstract ID: 4782
Poster ID: P2569
Poster Open Date/Time: Oct 11, 9:00 AM
Authors: Giampiero Girolomoni, Steven Feldman, Alexander Egeberg, Luis Puig Sanz, Hojung Jung, Younjin Park, Younju Lee
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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 biologic candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, endocrinology and gastroenterology. For more information, please visit: www.samsungbioepis.com
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1 Stelara is a trademark of Janssen Pharmaceuticals.
2 Humira is a trademark of AbbVie Biotechnology Ltd.
3 2022 Q3 Biogen Earnings presentation.