Review article: pharmacological aspects of anti‐TNF biosimilars in inflammatory bowel diseases. Issue 10 (13th September 2015)

• Record Type: Journal Article
• Authors: Papamichael, K.; Van Stappen, T.; Jairath, V.; Gecse, K.; Khanna, R.; D'Haens, G.; Vermeire, S.; Gils, A.; Feagan, B. G.; Levesque, B. G.; Vande Casteele, N.
• Is Part Of: Alimentary pharmacology & therapeutics. Volume 42:Issue 10(2015)
• Page Start: 1158
• Page End: 1169
• Publication Date: 2015-09-13
• Subjects: Digestive organs -- Diseases -- Treatment -- Periodicals; Digestive organs -- Effect of drugs on -- Periodicals; Gastrointestinal system -- Diseases -- Treatment -- Periodicals; Gastrointestinal system -- Effect of drugs on -- Periodicals; 615.73
• DOI: 10.1111/apt.13402
• Languages: English
• ISSNs: 0269-2813

Abstract

<abstract abstract-type="main" id="apt13402-abs-0001"> <title>Summary</title> <sec id="apt13402-sec-0001" sec-type="section"> <title>Background</title> <p>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.</p> </sec> <sec id="apt13402-sec-0002" sec-type="section"> <title>Aim</title> <p>To review the literature on anti‐TNF biosimilars focusing on pharmacokinetics, pharmacodynamic properties and comparative effectiveness, related to their use in IBD.</p> </sec> <sec id="apt13402-sec-0003" sec-type="section"> <title>Methods</title> <p>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.'</p> </sec> <sec id="apt13402-sec-0004" sec-type="section"> <title>Results</title> <p>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.</p> </sec> <sec id="apt13402-sec-0005" sec-type="section"> <title>Conclusions</title> <p>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.</p> </sec> </abstract>