Although further studies are needed to confirm the long-term effects, recent studies have shown the infliximab biosimilar to be a safe, effective, and cost reducing treatment for inflammatory bowel diseases.
The infliximab (IFX) biosimilar CT-P13 (Remsima) is equally effective and safe as its reference drug at treating inflammatory bowel diseases (IBDs) while also being more cost effective, according to a recent study.
IBDs are a few of many chronic conditions which have had treatment affected by biological drugs, but the cost of biologics has risen in the past 2 decades. Biosimilars have proven to be a safe and effective alternative, both in adults and in pediatric patients.
Biosimilars, “highly similar” version of their reference drugs, have seen more use as the price of biologics rises or as patents expire. Clinical trials have primarily been used to prove their safety and effectiveness in adults. Recently, however, more data on the safety and effectiveness of biosimilars in pediatric patients has been recorded.
The European Society of Pediatric Gastroenterology, Hepatology and Nutrition found CT-P13 can be used as a reliable alternative to IFX in pediatric patients. Other pediatric studies have shown IFX biosimilars to be similarly safe and effective to the reference drug. As these studies were of a small sample size and varying follow-up lengths, more data is needed to confirm their accuracy.
In the pediatric population, there is a concern about the interchangeability between the CT-P13 biosimilar and the IFX reference drug. The safety of non-medical switching between the IFX drug to a biosimilar was tested in a systematic review, analyzing 44 studies consisting of 3 randomized controlled trials, 40 observational trials, and 1 case series. There were no negative impacts recorded on safety, efficacy, or immunogenicity, but the small number of randomized controlled trials leaves the data unconclusive.
Long term, biosimilars will reduce the cost of biologic therapy, making treatment more affordable and accessible. They are 15% to 45% cheaper than their reference drugs, and in Europe the price reductions on certain biosimilars have reached 80%.
Currently, biosimilars are deemed a safe and effective substitute for treatment of IBDs. Further studies will be necessary to fill in the gaps in the data that is currently available.
1. Dipasquale V, Cucinotta U, Romano C. Biosimilars in pediatric IBD: updated considerations for disease management. Biologics. 2022;16:57-66. doi: 10.2147/BTT.S367032