title: Pharmacology and metabolism of infliximab biosimilars - A new treatment option in inflammatory bowel diseases.
abstract: Biological therapy with monoclonal antibodies to tumor necrosis factor alpha (TNF-α) was shown in large clinical trials to be effective in inducing and maintaining clinical remission in patients with moderate to severe Crohn's disease (CD) and ulcerative colitis (UC). Infliximab, the first anti-TNF-α biologic drug, has significantly improved inflammatory bowel disease (IBD) treatment outcomes by preventing structural damage progression, thereby reducing complications and the need for surgery and hospitalization. The major concern associated with the use of biologics is their high cost. However, as these therapies lose patent protection, cheaper biosimilar versions of the originator products are being developed, such as the infliximab biosimilar CT-P13. Position statements from several scientific societies and some experts in their reviews have expressed concerns to the concept of extrapolation without direct IBD clinical evidence, whereas European Medicines Agency (EMA) experts have supported extrapolation. In this review, we focus on the pharmacokinetics, pharmacodynamics properties and comparative effectiveness of anti-TNF-α biosimilars, related to their use in IBD.
authors.affiliation: Department of Gastroenterology, Medical University of Lodz, Łódź, Poland; Department of Biochemistry, Medical University of Lodz, Łódź, Poland; Department of General and Colorectal Surgery, Medical University of Lodz, Łódź, Poland. Electronic address: dr.mwlodarczyk@gmail.com.
authors.forename: Marcin
authors.initials: M
authors.lastname: Włodarczyk
authors.affiliation: Department of Biochemistry, Medical University of Lodz, Łódź, Poland.
authors.forename: Jakub
authors.initials: J
authors.lastname: Fichna
authors.affiliation: Department of Gastroenterology, Medical University of Lodz, Łódź, Poland; Department of Biochemistry, Medical University of Lodz, Łódź, Poland.
authors.forename: Aleksandra
authors.initials: A
authors.lastname: Sobolewska-Włodarczyk
mesh_terms: D000893:Anti-Inflammatory Agents / Q000493:pharmacokinetics / Q000494:pharmacology / Q000627:therapeutic use; D059451:Biosimilar Pharmaceuticals / Q000493:pharmacokinetics / Q000494:pharmacology / Q000627:therapeutic use; D006801:Humans; D007107:Immune System / Q000187:drug effects; D015212:Inflammatory Bowel Diseases / Q000188:drug therapy*; D000069285:Infliximab; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors*
chemical_list: D000893:Anti-Inflammatory Agents; D059451:Biosimilar Pharmaceuticals; D014409:Tumor Necrosis Factor-alpha; D000069285:Infliximab
keywords: Anti-TNF-α; Antibody; Biosimilars; Inflammatory bowel diseases