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Z Gastroenterol. 2016 Nov;54(11):1217-1222. Epub 2016 Oct 6.

[Biosimilars in inflammatory bowel disease].

[Article in German]

Author information

1
Medizinische Klinik für Gastroenterologie, Infektiologie, Rheumatologie, Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin, Hindenburgdamm, Berlin.
2
Medizinische Klinik 1, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen.
3
Gastroenterologische Gemeinschaftspraxis Minden, Minden.
4
Klinik für Gastroenterologie, Pulmologie und Allgemeine Innere Medizin, Evangelisches Krankenhaus Kalk, Köln.
5
Abteilung für Innere Medizin und Gastroenterologie, Sana Kliniken Ostholstein, Eutin.
6
DCCV e.V.,Berlin.
7
Klinik für Innere Medizin I, Universitätsklinikum Schleswig-Holstein, Kiel.
8
Medizinische Klinik, Klinikum Mannheim, Mannheim.
9
Medizinische Klinik I, Universitätsklinikum Carl Gustav Carus Dresden, Dresden.
10
Klinik für Allgemeine Innere Medizin und Gastroenterologie, Klinikum Lüneburg, Lüneburg.

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.

PMID:
27711946
DOI:
10.1055/s-0042-117648
[Indexed for MEDLINE]

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