title: IBD: Indication extrapolation for anti-TNF biosimilars.
abstract: Biosimilar monoclonal antibodies (mAbs) to TNF are being developed that are highly similar, but not identical to the innovator molecules. CT-P13, a biosimilar of infliximab, is the first anti-TNF mAb to get approval in South Korea, Europe and Canada. However, uncertainties remain about indication extrapolation and interchangeability.
authors.affiliation: Division of Gastroenterology, University of California San Diego, 9500 Gilman Drive, MC 0956, La Jolla, CA 92093-0956, USA.
authors.forename: Niels
authors.initials: N
authors.lastname: Vande Casteele
authors.affiliation: Division of Gastroenterology, University of California San Diego, 9500 Gilman Drive, MC 0956, La Jolla, CA 92093-0956, USA.
authors.forename: William J
authors.initials: WJ
authors.lastname: Sandborn
mesh_terms: D018033:Antibodies, Bispecific / Q000627:therapeutic use*; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D059451:Biosimilar Pharmaceuticals / Q000138:chemical synthesis; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D003424:Crohn Disease / Q000188:drug therapy*; D006801:Humans; D000069285:Infliximab / Q000494:pharmacology; D014409:Tumor Necrosis Factor-alpha / Q000187:drug effects
chemical_list: D018033:Antibodies, Bispecific; D000911:Antibodies, Monoclonal; D059451:Biosimilar Pharmaceuticals; C000591237:CT-P13; D014409:Tumor Necrosis Factor-alpha; D000069285:Infliximab