Biosimilars in inflammatory bowel disease

Siegmund B, Atreya R, Bokemeyer B, Kruis W, Mudter J, Sander C, Schreiber S, Reindl W, Zeissig S, Kucharzik T (2016)

Publication Type: Journal article

Publication year: 2016

Journal

Zeitschrift für Gastroenterologie Georg Thieme Verlag

Book Volume: 54

Pages Range: 1217-1222

Journal Issue: 11

DOI: 10.1055/s-0042-117648

Abstract

After the expiry date of the patent protection for Infliximab in 2013, the biosimilar CT-P13 was approved for indications in Crohn's disease and ulcerative colitis in adults as well as in children. The approval has been based on two randomized clinical studies indicating equivalence for the biosimilar with regard to pharmacokinetics, efficacy, as well as side-effects. The clinical experience since, in addition to multiple non-randomized studies, indicate a comparable efficacy and immunogenicity of the Infliximab biosimilar CT-P13 in inflammatory bowel disease. Thus, the introduction of the biosimilar as primary therapy seems to be justified. Tight monitoring of the safety of biosimilars with regard to efficacy and side effects has to be ensured.

Authors with CRIS profile

Raja Atreya Professur für Translationale Immunforschung bei chronisch entzündlichen Darmerkrankungen (Heisenberg-Professur)

Involved external institutions

Gastroenterologische Gemeinschaftspraxis Minden DE Germany (DE) Städtisches Klinikum Lüneburg DE Germany (DE) Universitätsklinikum Carl Gustav Carus Dresden DE Germany (DE) Universitätsklinikum Mannheim DE Germany (DE) Universitätsklinikum Schleswig-Holstein (UKSH) DE Germany (DE) Deutsche Morbus Crohn / Colitis ulcerosa Vereinigung (DCCV) e.V. DE Germany (DE) Sana Kliniken AG DE Germany (DE) Evangelisches Krankenhaus Kalk DE Germany (DE) Charité - Universitätsmedizin Berlin DE Germany (DE)

How to cite

APA:

Siegmund, B., Atreya, R., Bokemeyer, B., Kruis, W., Mudter, J., Sander, C.,... Kucharzik, T. (2016). Biosimilars in inflammatory bowel disease. Zeitschrift für Gastroenterologie, 54(11), 1217-1222. https://doi.org/10.1055/s-0042-117648

MLA:

Siegmund, B., et al. "Biosimilars in inflammatory bowel disease." Zeitschrift für Gastroenterologie 54.11 (2016): 1217-1222.

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