title: Biosimilar infliximab for inflammatory bowel disease: from concepts to clinical practice. Case study illustrated with CT-P13.
abstract: The introduction of biologic drugs represents the most significant advance in the management of immune-mediated inflammatory diseases for a decade. However, complex proteins are expensive to produce and manufacture. Biosimilar versions of established biologics are becoming available as another version of the reference medicinal product and are expected to provide substantial cost savings. However, because of their complexity, the approval of biosimilars requires strict controls to ensure that all therapeutically relevant characteristics are comparable to the reference medicinal product. This review summarizes the scientific principles and data requirements underpinning regulatory approval of biosimilars and the assumptions that enable extrapolation of data between indications. These important concepts are exemplified by CT-P13 (Remsima(®), Inflectra(®)), the first biosimilar monoclonal antibody approved in Europe.
authors.affiliation: a 1 Klinik für Innere Medizin I, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Germany.
authors.forename: Stefan
authors.initials: S
authors.lastname: Schreiber
authors.affiliation: b 2 Hospital Clínic de Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain.
authors.forename: Julian
authors.initials: J
authors.lastname: Panés
authors.affiliation: c 3 Celltrion, Incheon, Republic of Korea.
authors.forename: ByoungOh
authors.initials: B
authors.lastname: Kwon
authors.affiliation: c 3 Celltrion, Incheon, Republic of Korea.
authors.forename: SeungSuh
authors.initials: S
authors.lastname: Hong
authors.affiliation: d 4 Inserm U954 and Department of Gastroenterology, Nancy University Hospital, Universite de Lorraine, Vandoeuvre-les-Nancy, France.
authors.forename: Laurent
authors.initials: L
authors.lastname: Peyrin-Biroulet
mesh_terms: D000818:Animals; D000893:Anti-Inflammatory Agents / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D059451:Biosimilar Pharmaceuticals / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D017277:Drug Approval; D005765:Gastrointestinal Agents / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D006801:Humans; D015212:Inflammatory Bowel Diseases / Q000175:diagnosis / Q000188:drug therapy* / Q000276:immunology; D000069285:Infliximab / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D013810:Therapeutic Equivalency; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors* / Q000276:immunology
chemical_list: D000893:Anti-Inflammatory Agents; D000911:Antibodies, Monoclonal; D059451:Biosimilar Pharmaceuticals; C000591237:CT-P13; D005765:Gastrointestinal Agents; D014409:Tumor Necrosis Factor-alpha; D000069285:Infliximab
keywords: CT-P13; biosimilar; extrapolation; infliximab; manufacture; regulatory approval