Biosimilar treatment in paediatric gastroenterology – current view

Abstract

Biosimilar drugs (BSD) have been used in the field of gastroenterology since 2013, when the European Medicines Agency approved biosimilar infliximab for the treatment of inflammatory bowel disease (IBD). The view of these drugs has changed significantly in the course of their use. At first, BSDs were used with hesitation, mainly due to the lack of published data on their efficacy and safety and also due to the lack of clinical experience. Over the following years, a number of studies were published that gradually support their importance in the treatment of IBD, and BSDs are now routinely administered to patients naïve to biological treatment, and a number of centres perform switches from the original treatment to a BSD. In paediatrics, a more reserved attitude towards their clinical use persisted for a long time, but with the growing amount of published data, they are also common in clinical practice. This summary article describes the development in the approach of both international and domestic professional societies and physicians-clinicians to the use of BSL and provides references to newly published studies of biosimilar drugs. Keywords pediatrie, biosimilární léčiva, biologic therapy, evropská léková agentura, switch, extrapolace