Celltrion Healthcare: Experts share their “real world” experience of treating people with Inflammatory Bowel Disease (IBD) with biosimilar anti-TNFα monoclonal antibody (mAb)

Clinical experience presented today at the Celltrion Healthcare satellite symposium during UEGW 2014 builds the evidence base for treating patients with IBD (Crohn’s disease and ulcerative colitis) with a biosimilar monoclonal antibody (mAb) infliximab.

Infliximab is an anti-TNF therapy for treating patients with IBD^1,2,, and is considered a therapy for controlling disease symptoms over the long term.^3,4

Leading expert, Jørgen Jahnsen, Professor of Gastroenterology, University of Oslo, Norway, reported on his “real-world” clinical experience of treating people with both Crohn’s disease and ulcerative colitis with the first biosimilar mAb anti-TNFα approved by the European Medicines Agency (EMA) and licensed for use in Norway. A statistically significant reduction in disease activity at week fourteen was reported in 46 IBD patients (26 Crohn’s and 20 ulcerative colitis) following treatment with three infusions.

Commenting on his experience Prof Jahnsen said, “Whilst biologics have become increasingly important as a treatment option in IBD, they are also expensive which may mean that some patients have had limited access to them. The availability of a biosimilar anti-TNFα could contribute to improving patient access to advanced biologic treatments.”

Recent research has shown that, between 2007 and 2020, the use of biosimilars is expected to result in overall savings of between 11.8 billion and 33.4 billion Euros with biosimilar mAbs producing the greatest savings ranging from 1.8 to 20.4 billion Euros. ⁵

Biologic therapies in IBD are designed to target particular enzymes and proteins that have been proven defective, deficient, or excessive in people with Crohn’s disease or ulcerative colitis. Biologic agents act selectively, unlike conventional treatment with corticosteroids and other therapies, which tend to suppress the entire immune system and thereby risk producing major side effects. ⁶

ENDS

Notes to editors

About Celltrion Healthcare™

Celltrion Healthcare conducts the global marketing and sales activities for the distribution of Celltrion, Inc.'s biopharmaceutical products through its global network that covers over 120 different countries. Celltrion, Inc. is a leading biopharmaceutical company, specializing in monoclonal antibody biosimilars and novel biopharmaceuticals. Celltrion, Inc. focuses on the development of high quality biosimilars and novel antibody therapeutics that targeting various viral diseases, such as pandemic/seasonal influenzas and rabies.

REFERENCES

1. Jean Frederic Colombel, M.D., William J. Sandborn, M.D., Walter Reinisch, M.D., Gerassimos J. Mantzaris, M.D., Ph.D., Asher Kornbluth, M.D.,Daniel Rachmilewitz, M.D., Simon Lichtiger, M.D., Geert D’Haens, M.D., Ph.D.,Robert H. Diamond, M.D., Delma L. Broussard, M.D., Kezhen L. Tang, Ph.D.,C. Janneke van der Woude, M.D., Ph.D., and Paul Rutgeerts, M.D., Ph.D., Infliximab, for the SONIC Group. Azathioprine or Combination Therapy for Crohn’s Disease. N Engl J Med 2010;362:1383-9.

2. Stephen B Hanauer, Brian G Feagan, Gary R Lichtenstein, Lloyd F Mayer, S Schreiber, Jean Frederic Colombel,Daniel Rachmilewitz, Douglas C Wolf, Allan Olson, Weihang Bao, Paul Rutgeerts, and the ACCENT I Study Group*. Maintenance infliximab for Crohn’s disease: the ACCENT I randomised trial. The Lancet; Vol 359: 2002.

3. Van Assche G, Vermeire S, Ballet V, Gabriels F, Humblet E, Vande Casteele N, Gils A, Rutgeerts P. Switching Anti-TNFs in Crohn's Disease Classified by F1000 as 'Changes Clinical Practice. Gut. 2011 Sep 23. Medscape

4. Van Assche G. Immunmogenicity of anti-TNF antibodies. Has the veil been lifted? Gut 201160(3):285–286. Originally published online doi: 10.1136/gut.2009.199687.

5. J. Burisch et al. The Burden of Inflammatory Bowel Disease in Europe. Journal of Crohn's and Colitis (2013) 7, 322–337.

6. Biologic Therapies. Available from http://www.ccfa.org/resources/biologic-therapies.html. Accessed September 18, 2014.

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