The first
biosimilar infliximab,
CT-P13 infliximab-dyyb was approved in 2013 by the European Medicines Agency (EMA) and in 2016 by the United States Food and Drug Administration (FDA) and has been used for the treatment of
rheumatoid arthritis (RA) for 4 years. Areas covered:
CT-P13 with the three brand names on the market has highly similar efficacy and safety profiles but lower price than originator
infliximab and are approved in more than 80 countries. One of the most important determinants of the implementation of
CT-P13 in the treatment of RA is scientific evidence from clinical studies and real-world pharmacovigilance data. Here, we review all available clinical data supporting the similarity of
CT-P13 to originator
infliximab in its clinical efficacy and safety for the treatment of RA and related
arthritis. In addition, we consider the role of
CT-P13 in therapeutic strategies for RA treatment. Expert commentary: With its highly similar efficacy and safety profile to originator
infliximab and its lower price,
CT-P13 is expected to be very useful in RA treatment, whether it is applied earlier or switched from originator
infliximab or other biologics. Future educational initiatives will be important to overcome misunderstandings about
biosimilars and to improve the implementation of
CT-P13.