SAMSUNG-BIOEPIS
Samsung Bioepis Co., Ltd. today announced real-world data of BENEPALI™ 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 2019 European Academy of Dermatology and Venereology (EADV) Congress in Madrid, Spain.1
BADBIR is a UK and Ireland observational study that assesses the long-term safety of biologic treatments for psoriasis, in which Samsung Bioepis participated since May 2016. The study included BADBIR-registered patients treated with BENEPALI™ from January 01, 2016 to September 01, 2018. Among 269 patients who received BENEPALI™, clinical data of 189 patients were available, and were included in the analysis.
At baseline enrollment, the mean disease duration was 22.6 years and the mean Psoriasis Area and Severity Index (PASI) and Dermatology Life Quality Index (DLQI) scores were 11.6 and 13.1, respectively. The median treatment period was 14.1 months and the discontinuation rate was 26.3%. Of the 48 patients who had their PASI score available both at baseline and at six months, disease activity of 20 patients with baseline PASI < 10 (mean PASI 3.2) did not increase after six months (mean PASI 3.2). Disease activity of 28 patients with baseline PASI ≥ 10 (mean PASI 15.7) was reduced after six months (mean PASI 5.0).
“Results from this study show that BENEPALI was effective when used by patients in the real-life setting,” said Seongwon Han, MD, Vice President and Lead of Medical Team, Samsung Bioepis. “We hope the growing wealth of real-world data on BENEPALI will help physicians make informed decisions when treating patients with biosimilars.”
The results will be presented during an Oral Free Communication session scheduled at 15:40-15:50 on October 10, 2019 in N109-110. Samsung Bioepis and Biogen are also jointly hosting an Industry Hub Session titled “Shedding new light on the role of anti-TNFs in psoriasis” which will take place between 14:00-14:45 on October 10, 2019 in Room A9.1, IFEMA Ferida de Madrid, Spain. Topics include “Anti-TNFs in psoriasis: Will the use of more affordable options enhance current treatment algorithms?” and “Anti-TNF biosimilars: Real world insights and data.”
Samsung Bioepis and Biogen were the first to launch biosimilars of the three most prescribed anti-TNF therapies for immunological diseases across Europe: etanercept, infliximab and adalimumab.
About BENEPALITM (etanercept)
BENEPALI™ (etanercept), a biosimilar referencing ENBREL®2 , was approved by the European Commission (EC) in January 2016 for the treatment of adults with moderate to severe rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis (ankylosing spondylitis and non-radiographic axial spondyloarthritis), and plaque psoriasis. BENEPALI™ is currently available in 25 countries in Europe and is the most prescribed etanercept across France, Germany, Italy, Spain, and the United Kingdom combined.3
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 and hematology. Samsung Bioepis is a joint venture between Samsung BioLogics and Biogen. For more information, please visit: www.samsungbioepis.com .
1. Egeberg et al., Real World Data of SB4 (Etanercept Biosimilar) in Patients with Psoriasis from the British Association of Dermatologists Biologic Interventions Register (BADBIR). EADV 2019, Madrid, Spain
2. ENBREL®
is a registered trademark of Amgen/Pfizer.
3. Data on File: IQVIA, GERS, Insight Health ODV
View source version on businesswire.com: https://www.businesswire.com/news/home/20191008005493/en/
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Biocytogen and Acepodia Expand Collaboration Through Option-based Evaluation Framework for First-in-Class Bispecific and Dual-Payload ADCs (BsAD2C)9.1.2026 13:00:00 CET | Press release
Expanded collaboration builds on Acepodia and Biocytogen’s recent co-development efforts to evaluate selected bispecific antibody and dual-payload ADC programs Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen, SSE: 688796; HKEX: 02315) and Acepodia (6976:TT), today announced that the companies have entered into an option and license agreement designed to enable the structured evaluation of bispecific antibody-drug conjugate (BsADC) programs to further advance the development of dual-payload bispecific antibody-drug conjugates (BsAD2Cs). The agreement grants Acepodia an option to obtain an exclusive worldwide license from Biocytogen for two BsADC programs. Under the terms of the agreement, Biocytogen is eligible to receive an upfront option fee and, upon Acepodia’s exercise of the option, additional payments including option exercise fees, development, regulatory, and commercial milestone payments, as well as royalties on future product sales. The financial terms of the agreem
Blockstream Capital Partners Announces Strategic Acquisition of Derivatives Trading Team from Numeus Group, Leveraging Strategic Partnership with Komainu9.1.2026 11:08:00 CET | Press release
Blockstream Capital Partners (“BCP”) today announced that it has entered into a strategic agreement to acquire a division within Numeus Group’s digital asset trading and investment business. The transaction includes the absorption of select Bitcoin focused trading strategies with a focus on yield generation as well as a ten person derivatives trading team led by Chief Investment Officer Deepak Gulati, a specialist in volatility and derivatives markets. Deepak Gulati, appointed Co-Chief Investment Officer of Blockstream Capital Management alongside Rodrigo Rodriguez, previously served as Global Head of Proprietary Trading at JPMorgan, before founding Argentiere Capital, a multibillion-dollar volatility-focused hedge fund. With a thesis that derivatives would drive Bitcoin and digital asset market maturity, he co-founded Numeus Group in 2021 to develop institutional-grade trading, risk management and market-structure capabilities. Komainu, an existing BCP strategic investment, has played
Autel Unveils Strategic Shift at CES 2026: Building the AI-Powered Infrastructure of Future Cities9.1.2026 10:44:00 CET | Press release
At the Consumer Electronics Show (CES), Autel Energy is presenting its latest AI-driven smart hardware and software systems for the future of intelligent urban operations. This year’s showcase highlights Autel’s shift from AI concept validation to scenario-based engineering deployment, emphasizing closed-loop execution across real-world infrastructure. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260101511436/en/ Autel Energy New Product Debut at CES 2026 Focusing on two key domains — Smart Energy and Smart Inspection — the company is unveiling a range of new products. In Smart Energy, Autel is introducing V2G (Vehicle-to-Grid) AC charger for homes and DC charging solution for fleets, strengthening its multi-tier energy touchpoint strategy from households to commercial operations. Live demonstrations at the booth will feature a smart charging robot showcasing automated plug-in capabilities. In Smart Inspection, Autel will
Allianz and Anthropic Forge Global Partnership to Advance Responsible AI in Insurance9.1.2026 10:00:00 CET | Press release
Anthropic’s safety-first AI meets Allianz's dedication to customer centricity, stakeholder trust, and regulatory excellenceThree focus areas of the partnership: workforce empowerment, operations automation through agentic AI, and regulatory compliance Allianz SE and Anthropic today announced a global partnership to accelerate the adoption of responsible Artificial Intelligence (AI) at Allianz. The collaboration centers on three transformative projects within Allianz Group designed to empower Allianz employees and accelerate operations, while setting new benchmarks for accuracy. “With this partnership, Allianz is taking a decisive step to address critical AI challenges in insurance. Anthropic’s focus on safety and transparency complements our strong dedication to customer excellence and stakeholder trust. Together, we are building solutions that prioritize what matters most to our customers while setting new standards for innovation and resilience,” said Oliver Bäte, CEO of Allianz SE.
MRM Health Secures FDA IND Clearance to Launch its Phase 2b Trial of MH002 in Mild-to-Moderate Ulcerative Colitis9.1.2026 07:00:00 CET | Press release
MH002 is currently the most advanced Live Biotherapeutic Product (LBP) based on a rationally-designed combination of disease specific bacteria (microbial consortia), for the treatment of inflammatory bowel diseases (IBD) STARFISH-UC Phase 2b trial is designed to confirm MH002’s early efficacy signals and favorable safety observed in Phase 2a studies MRM Health NV, a clinical-stage biopharmaceutical company pioneering microbiome-based therapeutics for inflammatory diseases and immune-oncology, today announced that the U.S. Food and Drug Administration (FDA) has granted clearance of its Investigational New Drug (IND) application for its lead program MH002. This enables the initiation of the STARFISH-UC Phase 2b clinical trial in patients with mild-to-moderate ulcerative colitis, marking a significant step forward in the development of next-generation therapies for inflammatory bowel diseases (IBD). About the STARFISH-UC Phase 2b Trial The STARFISH-UC trial is a randomized, double-blind,
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom