A new analysis of available data strongly confirms the equivalence of reference infliximab and CT-P13, and data are reassuring about the switching approach from the reference drug to biosimilar.
The introduction of tumor necrosis factor (TNF) alpha inhibitors transformed treatment of conditions such as rheumatoid arthritis (RA), psoriatic arthritis, and ankylosing spondylitis (AS). TNF inhibitors have been shown in both studies and real-life experience to have favorable efficacy and safety profiles in these indications. However, the high costs of TNF inhibitors has led some countries to implement budget-restriction policies that potentially limit patient access to these drugs. Although the development of lower-cost biosimilars such as CT-P13 (the first biosimilar of infliximab introduced in the rheumatology field) can address unmet medical needs by widening access to expensive biological therapies, efficacy and safety concerns have been raised about potential differences between biosimilars and their reference products. Furthermore, recent surveys suggest that many physician specialists have only a basic knowledge of biosimilars; nearly a quarter cannot define or have not heard the term biosimilar.
Seeking to further clarify the use of biosimilars, Andrea Becciolini, MD, of the Department of Rheumatology, University of Milan, and coauthors conducted a comparability analysis of the infliximab biosimilar CT-P13 (Inflectra) and its reference product (Remicade). The analysis, which was published online in Drug Design, Development and Therapy, concludes that biosimilar CT-P13 is a valid treatment option for patients with RA and other rheumatologic conditions. “CT-P13 and [Remicade] showed a similar profile in terms of quality, biological activity, safety, immunogenicity, and efficacy,” the authors said, but they note that the issue of interchangeability between the reference infliximab and its biosimilar remains a challenge because of a lack of available long-term data.
The researchers evaluated equivalence randomized controlled trials (RCTs), including PLANETRA and PLANETAS. Their review explores the important findings from the literature concerning the following issues:
In conclusion, the researchers say that available data strongly confirm the equivalence of reference infliximab and CT-P13 from a PD and clinical point of view, and that the data are reassuring about the switching approach from the reference drug to biosimilar. “The findings suggest interchangeability between [Remicade] and CT-P13 as a feasible and safe strategy to be applied in real-life clinical practice,” the authors conclude. “Additional data from future clinical trials designed with the aim of specifically evaluating multiple interchangeability between [Remicade] and all its biosimilars should be advocated in order to improve our approach in the management of this condition.”