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
Suzano Reports Increased Operational Efficiency With Lower Cash Cost in the Third Quarter of 20256.11.2025 23:58:00 CET | Press release
Ongoing improvement in cost competitiveness: cash production costs continue to reduce (down 7% Y-o-Y), due to the increased contribution from the Ribas do Rio Pardo unit. Continued progress in integrating recent acquisitions: Suzano Packaging reported its first positive Adjusted EBITDA from the US operations acquired one year ago. Suzano, the world’s largest pulp producer, announces its results for the third quarter of 2025 (3Q25), reporting sales of 3.6 million tonnes of pulp and paper combined, a 20% increase on the same quarter last year (3Q24). The positive result is driven by the operations of the Ribas do Rio Pardo pulp mill, inaugurated in 2024, and by the integration of paper production from assets acquired in the United States in October 2024. The cash cost of pulp production (excluding downtime) was R$801 per tonne, a 7% reduction compared to 3Q24, another positive highlight of the quarter. The results reflect the continuation of the downward trend in production costs and the
Vedanta Resources Launches CopperTech Metals to Bolster U.S. Copper Security and Advance Technology and Infrastructure Transformation6.11.2025 17:45:00 CET | Press release
CopperTech Metals Combines World-Class Konkola Mines' Copper and Cobalt Producing Heritage with Cutting-Edge Mining Technology and Artificial Intelligence to Advance U.S. Critical Mineral Independence and Serve America's Growing Infrastructure Needs$1.5 Billion Investment Program to Leverage Advanced Mining and Cutting-Edge AI-Driven Resource Identification and Extraction Technology to Propel Konkola's Operations into One of the Largest in the World Vedanta Resources Limited ("Vedanta") today announced the launch of CopperTech Metals Inc. ("CopperTech" or the "Company"), a U.S.-domiciled company with a mission to 'Power the Copper Century' and to bolster America's copper security needs while capitalizing on surging copper demand driven by artificial intelligence, data center expansion, grid modernization, defense technologies and industrial onshoring requirements. CopperTech will1 own and operate the Konkola Copper Mines in Zambia, one of the highest-grade copper producing assets in th
NJ Bio Bridges the Translation Research Gap with the Asset Purchase and Integration of L2P®Services6.11.2025 17:11:00 CET | Press release
NJ Bio, Inc., a premier contract research and clinical manufacturing service provider in Princeton, New Jersey has announced the asset purchase and full integration of the research services of L2P Research Labs® (“Lab to Pharmacy”), further expanding its service portfolio, and bridging the translational research gap. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251106703527/en/ NJ Bio, Inc. now offers translational research services after completing asset purchase and full integration of the services of L2P® Research Labs, enhancing the discovery-to-development pipeline Currently, the attrition rate of biological molecules moving past phase 1 clinical trials is very high and the way to overcome this challenge is through translational research. NJ Bio specializes in preclinical and early-phase clinical research and development, with a primary focus on ADCs, bioconjugation, custom synthesis, oligonucleotides, and mRNAs. Howe
DevvStream Reports Fiscal Year 2025 Results and Advances Digital-Asset and Tokenization Strategy6.11.2025 17:01:00 CET | Press release
Company strengthens balance sheet, launches disciplined digital-asset treasury, and sets stage for acquisition-led growth in sustainability markets DevvStream Corp. (Nasdaq: DEVS) (“DevvStream” or the “Company”), a leading carbon management and environmental-asset monetization firm, today announced financial results for its fiscal year ended July 31, 2025, and provided an update on strategic initiatives designed to enhance liquidity, expand technology capabilities, and position the Company for scalable, acquisition-driven growth. Fiscal 2025 Highlights Completed Nasdaq listing and de-SPAC transaction, establishing DevvStream as one of the few publicly traded pure plays in carbon and renewable-energy asset monetization. Closed initial $10 million tranche under the Helena $300 million convertible-note facility, providing liquidity to launch the Company’s digital-asset treasury. Reported initial revenue as the Company begins monetizing its environmental-asset pipeline. Successfully comple
BST Global Launches 2026 AI + Data Impact Survey for the AEC Industry6.11.2025 16:41:00 CET | Press release
BST Global, the leading provider of AI-powered project intelligence™ solutions for the AEC industry, has launched its second annual global AI + Data Survey. Seeking insights from technology and data leaders of architecture, engineering and environmental consultancies around the world, the survey will be available until 11:59 p.m. ET, December 31, 2025. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251105615222/en/ BST Global, the leading provider of AI-powered project intelligence™ solutions for the AEC industry, has launched its second annual global AI + Data Survey. Seeking insights from technology and data leaders of architecture, engineering and environmental consultancies around the world, the survey will be available until 11:59 p.m. ET, December 31, 2025. Conducted in partnership with BST Global’s AI + Data Consortium and the American Council of Engineering Companies' (ACEC) Technology Committee, the survey focuses s
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