Ann Gils and her colleagues from KU Leuven evaluated if the biosimilars RemsimaTM and Inflectra® were equally well quantified as Remicade® (Infliximab, IFX) in their clinically validated infliximab assay.
The researchers demonstrated that the assay shows identical reactivity towards RemsimaTM and Inflectra® as to Remicade® and is well suited for therapeutic drug monitoring (TDM) of the biosimilars.
Relevance of therapeutic drug monitoring
Therapeutic Drug Monitoring (TDM) is a means by which drug concentrations in a patients’ blood can be monitored. In many cases, TDM is crucial for the success of the treatment as the bioavailability is relevant for a drug to work. Drug levels vary due to individual pharmacokinetics. TDM helps to optimize the treatment of patients by adjusting the dose to the individually required level, moreover it helps to reduce treatment cost.
To learn more about the relevance of TDM, please read the TAXIT study.
Infliximab and its biosimilars
Infliximab (IFX) is a chimeric antibody directed against the pro-inflammatory cytokine TNFα, a so-called TNFα-blocker. It is used for a number of inflammatory diseases such as Ulcerative colitis and Crohn’s disease.
The drug Remicade® was protected by patent till 2014. The biosimilars RemsimaTM and Inflectra® have been approved by the European Medicine´s Agency (EMA).