After expiry of the patent of originator anti-tumor necrosis factor drug infliximab (Remicade), CT-P13 was in 2013 the first infliximab biosimilar to be approved by the European Medicine Agency (EMA) for the same indications as the reference drug, including paediatric inflammatory bowel disease (IBD). The approval was based on extrapolation, after extensive in-vitro studies and clinical experience in patients with ankylosing spondylitis and rheumatoid arthritis. The extrapolation of CT-P13 to IBD and to paediatric patients raised concerns among paediatric IBD specialists.
Now, almost 4 years later, we can conclude that those concerns have been resolved. There are a growing number of postmarketing studies and real-life data, so far mostly in adults and some in children with IBD. These studies show reassuring comparable efficacy, safety and immunogenicity between CT-P13 and the reference Infliximab.
In Europe, biosimilars are increasingly regularly prescribed drugs in paediatric IBD. Due to their lower cost, treatment expenses have gone down considerably (up to 30% or more in some countries) and patient access has improved. However, additional well designed studies to investigate long term follow-up of biosimilars in children are still needed. In addition, clinical studies addressing pharmacokinetics, pharmacodynamics and optimal use of infliximab (originator as well as biosimilar) are still desirable.