Efficacy, safety, and pharmacokinetics of anti-TNF-α biosimilars in pediatric patients with inflammatory bowel diseases

Biologic drugs have radically modified the treatment of several chronic conditions, including inflammatory bowel diseases (IBD). Biologics, on the other hand, have been linked to increasing direct medical costs during the past two decades. Because the reference medications' patents had expired, the development and marketing of biosimilars under expedited licensing channels provided an affordable option for patients who met the criteria for biologics. Many pediatric IBD patients are now using biosimilars, with growing trends in recent years. However, data on the effectiveness and safety of biosimilars in pediatric IBD are still limited. The first section of this dissertation reports on real-life, original data on the effectiveness, immunogenicity, and safety of these drugs, as well as data from a nationwide survey that provides the opinions and barriers of biosimilar use by pediatric gastroenterologists in Italy. The second section of this dissertation presents the findings of a systematic review of previous studies on the use of anti-TNF-α biosimilars in pediatric IBD in order to provide context for fully understanding the evidence, knowledge gaps, and issues associated with the use of these drugs in children.