• Samsung Bioepis and Biogen present nine abstracts focusing on real-world evidence confirming the safety and efficacy of anti-TNF biosimilars and adherence among switched patients

• Samsung Bioepis and Biogen are the first in Europe to have available biosimilars referencing the three most prescribed anti-TNF biologic treatments, with approximately 145,000 patients currently on treatment¹


INCHEON, KOREA – June 12, 2019 – Samsung Bioepis Co., Ltd. today announced that its anti-TNF biosimilars portfolio will be the subject of nine presentations at the Annual European Congress of Rheumatology (EULAR 2019) in Madrid, Spain (June 12–15). The abstracts include real-world data for Samsung Bioepis’ anti-TNF portfolio, namely BENEPALI™ (etanercept), FLIXABI™ (infliximab), and IMRALDI™ (adalimumab).
 

“We hope the growing wealth of real-world data on our anti-TNF medicines will help physicians make informed decisions when transitioning patients to biosimilars,” said Chul Kim, Senior Vice President and Head of Clinical Sciences Division, Samsung Bioepis. “We remain committed to advancing our strong pipeline of biosimilar candidates, so that more patients and healthcare systems across Europe will be able to benefit from biosimilars.”
 

To compile real-world evidence, physicians ask patients open-ended questions about treatment experience. The real-world data to be presented at EULAR this year provide further insight into patient experience with anti-TNF biosimilars, including adherence data.
 

Data to be presented include results of the real-world data generating BENEFIT study, which evaluated the outcomes of transition from the reference product etanercept to its biosimilar in routine clinical practice. The study demonstrated no clinically significant difference in disease score from baseline to six months post transition in 533 patients suffering from rheumatoid arthritis (RA) and axial spondyloarthritis (axSpA).² (June 14, 11:45-13:30 CET – FRI0103 – Hall 10)
 

Additionally, data from a pooled analysis of etanercept, infliximab and adalimumab biosimilars and reference products across 1,461 patients will be presented. The analysis demonstrated similar outcomes between biosimilars and their respective reference products in terms of disease fluctuation at six months and one year of treatment.³ (June 15, 10:30-12:00 CET – SAT0162 – Hall 10)
 

Further abstracts evaluating the efficacy, safety, and retention rates of anti-TNF biosimilars in rheumatology include⁴:

• [OPO236] Glintborg et al. ARTIS: Similar one-year treatment retention of originator and biosimilar etanercept. Results of a Nordic collaboration including 1,015 patients with spondyloarthritis. (June 14, 10:15-11:45 CET – Hall 7A)
• [SAT0134] Baganz et al. RABBIT: Comparing real-world retention rates in a matched cohort of rheumatoid arthritis patients who either remained on the etanercept originator or switched to a biosimilar. (June 15, 10:30-12:00 CET – Hall 10)
• [SAT0146] Haugeberg et al. Drug survival for biosimilar SB4 etanercept in rheumatoid arthritis both etanercept naïve and non-medical switch patients with etanercept reference drug in a Norwegian out-patient clinic. Preliminary results from a multi-center study. (June 15, 10:30-12:00 CET – Hall 10)
• [FRI0094] Haugeberg et al. Long-term drug survival for biosimilar SB4 etanercept in RA, PsA and aSpA patients with a non-medical switch from etanercept reference drug. (June 14, 11:45-13:30 CET -  Hall 10)
• FRI0101] Kiltz et al. Non-medical switching from originator to biosimilar etanercept - no evidence for a relevant nocebo effect – a retrospective analysis of real-life data. (June 14, 11:45-13:30 CET – Hall 10)
• [SAT0141] Rebecca Davies et al. BSRBR: Frequency and reasons for switching back to biologic originator following initial switch to biologic biosimilar. (June 15, 10:30-12:00 CET– Hall 10)
• [ABSTRACT ONLY]  Ruiz-Argüello et al. Validation of a therapeutic drug monitoring test to measure the adalimumab biosimilar SB5 in comparison to the reference adalimumab (ENCORE).
 

About BENEPALI™ (etanercept)
BENEPALI™ (etanercept), a biosimilar referencing ENBREL® ⁵, 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 in the five largest European countries (Germany, UK, France, Italy, and Spain).⁶

About FLIXABI™ (infliximab)
FLIXABI™ (infliximab), a biosimilar referencing REMICADE® ⁷, was approved by the European Commission (EC) in May 2016 for the treatment of adults with rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis or psoriasis. FLIXABI™ can also be used in patients 6–17 years old with severe, active Crohn’s disease or severely active ulcerative colitis when they have not responded to or cannot take other medicines or treatments. FLIXABI™ is currently available in 17 countries in Europe. ⁸

About IMRALDI™ (adalimumab)
IMRALDI™ (adalimumab), a biosimilar referencing HUMIRA® ⁹ was approved by the European Commission (EC) in August 2017 for the treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and active enthesitis-related arthritis, axial spondyloarthritis, psoriatic arthritis, plaque psoriasis, hidradenitis suppurativa, Crohn’s disease, ulcerative colitis and non-infectious uveitis. IMRALDI™ is currently available in 18 countries in Europe and is the leading adalimumab biosimilar in Germany and In Europe.^10,11

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.

References:
1. Biogen data on file.
2. Kruger et al. BENEFIT Study: A Pan-European Observational Study to Evaluate Real-world Effectiveness of SB4 Following Transition from Originator Etanercept (ETN) in Patients with Rheumatoid Arthritis (RA) or Axial Spondyloarthritis (AxSpA). Annual European Congress of Rheumatology (EULAR 2019).
3. Smolen et al. A pooled analysis of 1-year clinical outcome by 6-month disease activity from three TNF inhibitor biosimilar studies in patients with rheumatoid arthritis. EULAR 2019.
4. Data from Biogen- and Samsung Bioepis- supported studies.
5. ENBREL® is a registered trademark of Wyeth LLC.
6. Data on File: IQVIA, GERS, Insight Health ODV
7. REMICADE® is a registered trademark of Janssen Biotech, Inc.
8. Data on File: IQVIA, GERS, Insight Health ODV
9. HUMIRA® is a registered trademark of AbbVie Biotechnology Ltd.
10. Data on File: IQVIA, GERS, Insight Health ODV
11. Data on File: Biogen, Inc. Q1 First Quarter 2019 Financial Results and Business Update. April 24th, 2019