Biosimilar infliximab in paediatric inflammatory bowel disease: Efficacy, immunogenicity and safety

Abstract

What is known and objective Based on extrapolation, biosimilar infliximab (IFX) was approved to treat inflammatory bowel disease (IBD). The first studies in adults have shown similar efficacy and safety in comparison with reference drug. The aim of this review was to collect and evaluate all the literature data regarding the use of biosimilar IFX in paediatric IBD. Methods This article reviewed efficacy, immunogenicity and safety profile of biosimilar IFX in IBD paediatric patients through a comprehensive search of the published literature. Results and discussion Eight papers were extracted and critically reviewed. Four paediatric studies (prospective, n = 3; retrospective, n = 1) assessed the induction efficacy of the biosimilar IFX. Clinical response and remission rates reported were 86%‐90% and 67%‐68%, respectively. No significant difference in clinical response and remission rates between the reference and biosimilar IFX groups was found at follow‐up (range: 3‐13 months). Similar findings were shown in the prospective studies (n = 4) conducted on patients elected to switch from reference IFX to its biosimilar. The most frequently reported adverse events (AEs) of biosimilar IFX were mild upper respiratory tract infections. Taking into account of all AEs coming from published data, biosimilar IFX seems to be as safe as its originator. Immunogenicity has not been significantly impacted by the switch from the reference drug. What is new and conclusion To date, treatment with (or switch to) biosimilar IFX in paediatric patients with IBD have been successful, without affecting efficacy, immunogenicity or safety. However, further studies are warranted, including clinical trials and pharmacovigilance studies.

Biosimilars in Pediatric Inflammatory Bowel Diseases: A Systematic Review and Real Life-Based Evidence

“…Because the originator IFX is often no longer available, most IBD units have had to switch to or to start with its biosimilars ( de Ridder et al, 2019 ; Dipasquale and Romano, 2020 ). Access to the originator IFX is also often limited due to the originator’s relatively expensive cost ( de Ridder et al, 2019 ; Hughes et al, 2021 ).…”

“…Many pediatric IBD patients are now using biosimilars, with growing trends in recent years. Data on the effectiveness and safety of biosimilars in pediatric IBD are steadily increasing ( Dipasquale and Romano, 2020 ). CT-P13 can be regarded as a good alternative to the originator for induction and maintenance of remission in children with IBD, according to the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition (ESPGHAN) Pediatric IBD Porto Group ( de Ridder et al, 2015 ; de Ridder et al, 2019 ).…”

Real-Life Use of Biosimilars in Pediatric Inflammatory Bowel Disease: A Nation-Wide Web Survey on Behalf of the SIGENP IBD Working Group

“…Biosimilars are currently used in many pediatric IBD patients, with rising trends over recent years [3,4]. The ESPGHAN Pediatric IBD Porto Group stated that CT-P13 can be considered as a valid alternative to the originator for induction and maintenance of remission in children with IBD [3].…”

“…The unavailability of the reference infliximab has forced the switch to the biosimilar in most centers. Indeed, the relatively high cost of the originator is often a limiting factor regarding access to these drugs [3,4]. Some previously published studies investigated the switching of pediatric IBD patients to the biosimilar of infliximab [10][11][12][13].…”

“…The European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) Pediatric IBD Porto group provided consensusbased recommendations for pediatric gastroenterologists treating children with IBD [3]. In recent years, data on efficacy and safety of biosimilars in pediatric IBD are growing, even though they are still limited [3,4]. Meanwhile, the level of knowledge of physicians about this burning topic is unknown.…”