title: [Biosimilars in inflammatory bowel disease].
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.affiliation: Medizinische Klinik für Gastroenterologie, Infektiologie, Rheumatologie, Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin, Hindenburgdamm, Berlin.
authors.forename: B
authors.initials: B
authors.lastname: Siegmund
authors.affiliation: Medizinische Klinik 1, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen.
authors.forename: R
authors.initials: R
authors.lastname: Atreya
authors.affiliation: Gastroenterologische Gemeinschaftspraxis Minden, Minden.
authors.forename: B
authors.initials: B
authors.lastname: Bokemeyer
authors.affiliation: Klinik für Gastroenterologie, Pulmologie und Allgemeine Innere Medizin, Evangelisches Krankenhaus Kalk, Köln.
authors.forename: W
authors.initials: W
authors.lastname: Kruis
authors.affiliation: Abteilung für Innere Medizin und Gastroenterologie, Sana Kliniken Ostholstein, Eutin.
authors.forename: J
authors.initials: J
authors.lastname: Mudter
authors.affiliation: DCCV e.V.,Berlin.
authors.forename: C
authors.initials: C
authors.lastname: Sander
authors.affiliation: Klinik für Innere Medizin I, Universitätsklinikum Schleswig-Holstein, Kiel.
authors.forename: S
authors.initials: S
authors.lastname: Schreiber
authors.affiliation: Medizinische Klinik, Klinikum Mannheim, Mannheim.
authors.forename: W
authors.initials: W
authors.lastname: Reindl
authors.affiliation: Medizinische Klinik I, Universitätsklinikum Carl Gustav Carus Dresden, Dresden.
authors.forename: S
authors.initials: S
authors.lastname: Zeissig
authors.affiliation: Klinik für Allgemeine Innere Medizin und Gastroenterologie, Klinikum Lüneburg, Lüneburg.
authors.forename: T
authors.initials: T
authors.lastname: Kucharzik
mesh_terms: D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects; D059451:Biosimilar Pharmaceuticals / Q000008:administration & dosage* / Q000009:adverse effects; D017277:Drug Approval / Q000379:methods*; D057915:Drug Substitution / Q000639:trends*; D005062:European Union; D019317:Evidence-Based Medicine; D006801:Humans; D015212:Inflammatory Bowel Diseases / Q000175:diagnosis / Q000188:drug therapy*; D016032:Randomized Controlled Trials as Topic; D013810:Therapeutic Equivalency; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D059451:Biosimilar Pharmaceuticals; C000591237:CT-P13