Published online Sep 21, 2018. doi: 10.3748/wjg.v24.i35.4021
Peer-review started: June 7, 2018
First decision: July 12, 2018
Revised: August 14, 2018
Accepted: August 24, 2018
Article in press: August 24, 2018
Published online: September 21, 2018
The introduction of biological treatments has changed disease outcomes for patients with inflammatory bowel disease. Biologicals have high efficacy, and can induce and maintain remission after failed responses to conventional immunosuppressive and/or steroid therapy. The increasing occurrence of severe disease at diagnosis has resulted in infliximab being more often introduced as the first-line treatment in a “top-down” approach. Besides their favourable efficacy and safety profile, biologicals have one significant disadvantage, which is their high cost. This results in many patients stopping therapy prematurely, with the maintenance phase being too short. This often leads to disease exacerbation shortly after treatment cessation. Every newly started course of biological therapy can induce production of anti-drug antibodies, which can result in treatment failure and possible allergic/anaphylactic reactions. The introduction of biological biosimilars was intended to greatly reduce therapy costs thus increasing the availability of these agents to more patients. It was also anticipated that biosimilars would prevent premature termination of therapy. Analyses of paediatric data suggest that biosimilar infliximabs are equally effective as the reference infliximab. Safety patterns also seem to be similar. Paediatric experience places cost-therapy reductions at around 10%-30%.
Core tip: Data on the use of biosimilars among paediatric patients are limited. Nevertheless, several original papers support adult findings that biosimilars are as effective and safe as the reference infliximab in this population.