• Samsung Bioepis and Biogen to present one abstract and one poster at EULAR 2022 on adalimumab biosimilar, SB5 including Phase 1 study of a new SB5 formulation and a pan-European real-world study, PROPER
• Abstract and poster of the studies are available online at EULAR 2022 website
INCHEON, Korea – June 1 2022 – Samsung Bioepis Co., Ltd. today announced that new data on its adalimumab biosimilar IMRALDI™ (SB5), known as HADLIMA™ outside Europe, will be presented at the upcoming Annual European Congress of Rheumatology (EULAR 2022), which is being held both virtually through the Congress platform and on-site in Copenhagen, Denmark between June 1-4, 2022.
“The addition of new data to our adalimumab biosimilar, SB5 is great news for patients with rheumatic and other inflammatory diseases,” said Donghoon Shin, Vice President and Medical & Lifecycle Safety Team Leader at Samsung Bioepis. “Samsung Bioepis has been constantly developing our data package for all our products and we are very pleased to be providing additional evidence which further demonstrates our dedication and commitment to providing quality biologic medicines.”
“We are very pleased with the results of the PROPER study which adds to the body of real-world evidence for our biosimilars, offering significant clinical insights for treatment optimization of patients with rheumatoid arthritis,” said Mourad Farouk Rezk, Head of Global Medical and Development Biosimilars at Biogen. “Real-world evidence from studies like PROPER can provide meaningful insights on the use of anti-TNF biosimilars in clinical settings and can advance the understanding of their potential role in managing chronic immune mediated inflammatory diseases.”
Highlights of the data are as follows:
A new formulation of SB5 (adalimumab biosimilar) Phase 1 study1 :
The Phase 1 clinical trial compares the pharmacokinetic (PK), safety, and tolerability profile of the new SB5 formulation (40 mg/0.4 mL) with the original SB5 formulation (40 mg/0.8 mL) in healthy male subjects. In a randomized, single-blind, two-arm, parallel group, single-dose study in healthy subjects, the study demonstrated PK equivalence between the new SB5 formulation and the original SB5 formulation. Both formulations of SB5 were generally well tolerated with similar safety profiles.
The ‘PROPER’ Study2 :
This real-world study, sponsored by Biogen GmbH, is designed to provide insights into outcomes of the transition from reference adalimumab to adalimumab biosimilar (SB5). Under an umbrella design, over 1,000 patients with a diagnosis of rheumatoid arthritis (RA), axial spondyloarthritis (axSpA), psoriatic arthritis (PsA), ulcerative colitis or Crohn’s disease were enrolled following transition to SB5 as part of routine treatment following a minimum of 16 weeks’ treatment with reference adalimumab. Data were captured from patient records retrospectively for 24 weeks prior to and prospectively and/or retrospectively up to 48 weeks after SB5 initiation. The study showed that treatment effectiveness was maintained at 48 weeks after switching from reference adalimumab to SB5, with most patients continuing on SB5 throughout.
SB5 was approved by the European Commission (EC) in August 2017, under the brand name IMRALDI™ as a biosimilar to HUMIRA®3 . 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 247,000 patients in Europe alone4.
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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, endocrinology and gastroenterology. For more information, please visit: www.samsungbioepis.com
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1 S. Ahn et al. A Randomised Phase I Pharmacokinetic Study Comparing High-concentration, Low-volume, and Citrate-free SB5 (40 mg/0.4 mL) with Prior SB5 Formulation, an Adalimumab Biosimilar, in Healthy Male Subjects. Annual European Congress of Rheumatology (EULAR 2022).
2 Ulf Müller-Ladner et al. The PROPER Study: A 48-week analysis of a pan-EU real-world study of SB5 biosimilar following transition from reference adalimumab in patients with rheumatoid arthritis, axial spondyloarthritis or psoriatic. EULAR 2022.
3 HUMIRA® is a registered trademark of AbbVie Biotechnology Ltd.
4 Data on file: Biogen Q1 2022 earnings report.