Intest Res.  2016 Jan;14(1):15-20. 10.5217/ir.2016.14.1.15.

Current status of biosimilars in the treatment of inflammatory bowel diseases

Affiliations
  • 1Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea. diksmc.park@samsung.com

Abstract

Introduction
of biological therapies have led to dramatic changes in the management of debilitating immune-mediated inflammatory bowel diseases (IBD) including ulcerative colitis and Crohn's disease. However, the long term use of these agents may be very expensive, placing a significant burden on National Healthcare Systems. The development of first biosimilar to infliximab, CT-P13 (Remsima; Celltrion Inc., Incheon, Korea and Inflextra; Hospiral, Lake Forest, Illinois, USA) has become another way to decrease the medical care cost and increase patient treatment option, but, actual equivalence of efficacy and safety of CT-P13 was investigated in rheumatic diseases only. The extrapolation of outcome from rheumatic trials to IBD and the interchangeability of CT-P13 with infliximab have come to be a matter of concern. Two recent retrospective studies reported the similarity of CT-P13 in terms of efficacy and safety. Infliximab biosimilars may be promising new treatment options for IBD patients, however, well-designed, prospective randomized non-inferiority trials should be needed to confidently integrate infliximab biosimilars into IBD treatment.

Keyword

Inflammatory bowel diseases; Biosimilar; Pharmacy; CT-P13

MeSH Terms

Biological Therapy
Colitis, Ulcerative
Crohn Disease
Delivery of Health Care
Health Care Costs
Humans
Illinois
Incheon
Infliximab
Inflammatory Bowel Diseases*
Korea
Lakes
Pharmacy
Prospective Studies
Retrospective Studies
Rheumatic Diseases
Trees

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Infliximab biosimilar CT-P13 is interchangeable with its originator for patients with inflammatory bowel disease in real world practice
Tomoo Nakagawa, Taku Kobayashi, Kiyohiro Nishikawa, Fumika Yamada, Satoshi Asai, Yukinori Sameshima, Yasuo Suzuki, Mamoru Watanabe, Toshifumi Hibi
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