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

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 biosimi-lar IFX in paediatric IBD.Methods: This article reviewed efficacy, immunogenicity and safety profile of bio-similar IFX in IBD paediatric patients through a comprehensive search of the pub-lished 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 stud-ies (n = 4) conducted on patients elected to switch from reference IFX to its biosimi-lar. The most frequently reported adverse events (AEs) of biosimilar IFX were mild upper respiratory tract infections. Taking into account of all AEs coming from pub-lished 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, immu-nogenicity or safety. However, further studies are warranted, including clinical trials and pharmacovigilance studies