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 BENEPALI^TM (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

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