title: Biosimilars in inflammatory bowel disease: A review of post-marketing experience.
abstract: Biologic compounds are obtained from living organisms or cell cultures by means of biotechnology methods. A similar biologic drug, commonly called biosimilar, is a product copied by a native approved biologic drug whose license has expired. Biosimilar drugs usually are marketed at a lower price and provide important financial savings for public healthcare systems. Some differences between biosimilars and original biologic drugs might exist but they are acceptable if they fall within defined "boundaries of tolerance": differences in some features between the two molecules are considered important only if clinical relevant. Considering that the efficacy of the innovator biologic drug has already been established, the clinical studies required for approval of a biosimilar could be reduced compared with those required for the approval of the originator. In this review, real life data available in inflammatory bowel disease patients treated with biosimilars are reported, documenting in general satisfactory outcomes, sustained efficacy and no sign of increased immunogenicity, although, further controlled data are awaited.
authors.affiliation: Simona Deiana, Tommaso Gabbani, Vito Annese, Division of Gastroenterology, AOU Careggi University Hospital, 50139 Firenze, Italy.
authors.forename: Simona
authors.initials: S
authors.lastname: Deiana
authors.affiliation: Simona Deiana, Tommaso Gabbani, Vito Annese, Division of Gastroenterology, AOU Careggi University Hospital, 50139 Firenze, Italy.
authors.forename: Tommaso
authors.initials: T
authors.lastname: Gabbani
authors.affiliation: Simona Deiana, Tommaso Gabbani, Vito Annese, Division of Gastroenterology, AOU Careggi University Hospital, 50139 Firenze, Italy.
authors.forename: Vito
authors.initials: V
authors.lastname: Annese
mesh_terms: D000068879:Adalimumab / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000328:Adult; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001691:Biological Therapy / Q000379:methods; D059451:Biosimilar Pharmaceuticals / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D017277:Drug Approval; D006801:Humans; D015212:Inflammatory Bowel Diseases / Q000188:drug therapy*; D000069285:Infliximab / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011358:Product Surveillance, Postmarketing; D016032:Randomized Controlled Trials as Topic; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D059451:Biosimilar Pharmaceuticals; C000591237:CT-P13; D000069285:Infliximab; D000068879:Adalimumab
keywords: Adalimumab biosimilar; Biologic drugs; CTP-13; Infliximab biosimilars; ZRC-3197