• Long term follow-up data from British Association of Dermatologics and Immunomodulators Register (BADBIR) shows safety and effectiveness of SB5 in patients with psoriasis who have started or transitioned from reference adalimumab
INCHEON, Korea – September 07 2022 – Samsung Bioepis Co., Ltd. today announced 3-year follow-up data of its adalimumab biosimilar SB5 in patients with moderate to severe psoriasis from the British Association of Dermatologists Biologics and Immunomodulators Register (BADBIR). The results will be presented at the 2022 European Academy of Dermatology and Venereology (EADV) Congress in both Milan, Italy and online.1 BADBIR is 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.
“Long-term real-world data on the effectiveness and safety of adalimumab biosimilars in psoriasis is limited, and study results from BADBIR demonstrate that SB5 is just as safe and effective as its reference adalimumab,” said Jin Ah Jung, Director of Medical Affairs Group at Samsung Bioepis. “We hope that our continued efforts in providing real-world data help physicians and patients gain confidence in biosimilars.”
The study included 1,059 patients with psoriasis registered in BADBIR from June 01, 2019 to August 31, 2021 who were treated with SB5. Of the 1,059 enrolled patients, the persistence rate after three-year therapy was 72.1%.
SB5 treatments were discontinued in 275 out of 1,096 treatments (25.1%) and mean (± SD) SB5 treatment duration was 19.3 months ± 9.1. The cumulative persistence rate of SB5 year-one, -two and -three were 79.7%, 73.5%, and 72.1%, respectively.
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 253,000 patients in Europe alone.3
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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 Giampiero Girolomoni et al., 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)). EADV 2022, Milan, Italy
2 Humira is a trademark of AbbVie Biotechnology Ltd.
3 Biogen Q2 2022 earnings report.