title: Biosimilars in Inflammatory Bowel Disease - Accumulating Clinical Evidence.
abstract: Biologic antagonists to tumor necrosis factor alpha (TNF- α) are effective medications and have become well established in the treatment of both Crohn's disease and ulcerative colitis. Biosimilar medications, which are medications deemed to be equivalent to reference biologic products in terms of clinical effectiveness, safety, pharmacokinetic analysis, and immunogenicity, have now been approved in inflammatory bowel diseases (IBD) based on indication exploration from clinical data in alternate disease states. Clinicians use these products with caution secondary to lack of clinical experience. Areas Covered: The authors performed a literature search using the following keywords: CT-P13, biosimilar, adalimumab, infliximab, ABP 501, and inflammatory bowel disease. Bibliographies were also reviewed for pertinent articles. Articles pertaining to the clinical efficacy of biosimilars in IBD were included. Expert commentary: The phase 3 trials, which provided the clinical justification to bring TNF- α biosimilars to market, were in rheumatoid arthritis and ankylosing spondylitis; however, new clinical data suggests that biosimilar products have equivalent safety and efficacy to reference products in IBD. This has led to an increased acceptance amongst practicing gastroenterologists and a potential reduction in healthcare costs.
authors.affiliation: a Department of Pharmacy , Harper University Hospital , Detroit , MI , USA.
authors.forename: Sean
authors.initials: S
authors.lastname: McConachie
authors.affiliation: b Department of Pharmacy Practice, Eugene Applebaum College of Pharmacy and Health Sciences , Wayne State University , Detroit , MI , USA.|c Harper University Hospital , Detroit , MI , USA.
authors.forename: Sheila M
authors.initials: SM
authors.lastname: Wilhelm
authors.affiliation: b Department of Pharmacy Practice, Eugene Applebaum College of Pharmacy and Health Sciences , Wayne State University , Detroit , MI , USA.|d St. John Hospital and Medical Center , Detroit , MI , USA.
authors.forename: Pramodini B
authors.initials: PB
authors.lastname: Kale-Pradhan
mesh_terms: D001688:Biological Products / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology; D059451:Biosimilar Pharmaceuticals / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D003424:Crohn Disease / Q000188:drug therapy*; D015195:Drug Design; D005765:Gastrointestinal Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology; D006801:Humans; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors
chemical_list: D001688:Biological Products; D059451:Biosimilar Pharmaceuticals; D005765:Gastrointestinal Agents; D014409:Tumor Necrosis Factor-alpha
keywords: ABP-501; CT-P13; adalimumab; biosimilar; indication extrapolation; infliximab