title: Review article: pharmacological aspects of anti-TNF biosimilars in inflammatory bowel diseases.
abstract: BACKGROUND
  Anti-tumour necrosis factor (anti-TNF) monoclonal antibodies have shown efficacy in inflammatory bowel diseases (IBD). As these therapies lose patent protection, biosimilar versions of the originator products are being developed, such as the infliximab biosimilar CT-P13; however, some uncertainty exists regarding their pharmacology in IBD.
  
  
  OBJECTIVE
  To review the literature on anti-TNF biosimilars focusing on pharmacokinetics, pharmacodynamic properties and comparative effectiveness, related to their use in IBD.
  
  
  METHODS
  A PubMed literature search was performed using the following terms individually or in combination: 'biosimilars,' 'CT-P13,' 'Crohn's disease,' 'inflammatory bowel disease,' 'ulcerative colitis,' 'anti-TNFα therapy,' 'infliximab,' 'adalimumab,' 'pharmacokinetics,' 'immunogenicity.'
  
  
  RESULTS
  Bioequivalence of CT-P13 and infliximab was shown in ankylosing spondylitis (AS) and therapeutic equivalence in rheumatoid arthritis (RA). Preliminary results of CT-P13 in IBD come from small post-marketing registries and case series with a relatively short-term follow-up period and suggest comparable efficacy and safety to infliximab. Inter- and intra-individual differences in exposure and response are well known for the original molecules but dosing regimens and concomitant medications are different for RA compared to IBD, limiting the ability to translate some of the pharmacology data in RA to IBD. Uncertainty exists about cross-reactivity of anti-drug antibodies and whether similar exposure-response relationships will be observed for biosimilars and efficacy thresholds for therapeutic drug monitoring can be used interchangeably.
  
  
  CONCLUSIONS
  It is likely that biosimilars will be widely used for the treatment of IBD due to their cost savings and comparable efficacy. Nevertheless, robust post-marketing studies and pharmacovigilance are warranted in the coming years.
authors.affiliation: KU Leuven Department of Pharmaceutical and Pharmacological Sciences, Leuven, Belgium.|KU Leuven Department of Clinical and Experimental Medicine, Leuven, Belgium.
authors.forename: K
authors.initials: K
authors.lastname: Papamichael
authors.affiliation: KU Leuven Department of Pharmaceutical and Pharmacological Sciences, Leuven, Belgium.
authors.forename: T
authors.initials: T
authors.lastname: Van Stappen
authors.affiliation: Translational Gastroenterology Unit, Nuffield Department of Medicine, John Radcliffe Hospital, University of Oxford, Oxford, UK.
authors.forename: V
authors.initials: V
authors.lastname: Jairath
authors.affiliation: 1st Department of Medicine, Semmelweis University, Budapest, Hungary.
authors.forename: K
authors.initials: K
authors.lastname: Gecse
authors.affiliation: Robarts Clinical Trials Inc., London, ON, Canada.
authors.forename: R
authors.initials: R
authors.lastname: Khanna
authors.affiliation: Robarts Clinical Trials Inc., London, ON, Canada.|Department of Gastroenterology and Hepatology, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands.
authors.forename: G
authors.initials: G
authors.lastname: D'Haens
authors.affiliation: KU Leuven Department of Clinical and Experimental Medicine, Leuven, Belgium.
authors.forename: S
authors.initials: S
authors.lastname: Vermeire
authors.affiliation: KU Leuven Department of Pharmaceutical and Pharmacological Sciences, Leuven, Belgium.
authors.forename: A
authors.initials: A
authors.lastname: Gils
authors.affiliation: Robarts Clinical Trials Inc., London, ON, Canada.
authors.forename: B G
authors.initials: BG
authors.lastname: Feagan
authors.affiliation: Robarts Clinical Trials Inc., London, ON, Canada.|Division of Gastroenterology, University of California San Diego, La Jolla, CA, USA.
authors.forename: B G
authors.initials: BG
authors.lastname: Levesque
authors.affiliation: KU Leuven Department of Pharmaceutical and Pharmacological Sciences, Leuven, Belgium.|Division of Gastroenterology, University of California San Diego, La Jolla, CA, USA.
authors.forename: N
authors.initials: N
authors.lastname: Vande Casteele
mesh_terms: D000068879:Adalimumab / Q000627:therapeutic use; D000911:Antibodies, Monoclonal / Q000627:therapeutic use; D059451:Biosimilar Pharmaceuticals / Q000627:therapeutic use*; D003093:Colitis, Ulcerative / Q000188:drug therapy; D003424:Crohn Disease / Q000188:drug therapy; D016903:Drug Monitoring; D006801:Humans; D015212:Inflammatory Bowel Diseases / Q000188:drug therapy*; D000069285:Infliximab / Q000627:therapeutic use; D013810:Therapeutic Equivalency; D014409:Tumor Necrosis Factor-alpha / Q000627:therapeutic use*
chemical_list: D000911:Antibodies, Monoclonal; D059451:Biosimilar Pharmaceuticals; C000591237:CT-P13; D014409:Tumor Necrosis Factor-alpha; D000069285:Infliximab; D000068879:Adalimumab