CT-P13: design, development, and place in therapy

Abstract

The introduction of biological agents has revolutionized the management of many life-threatening and debilitating immune-mediated diseases. Because of the high cost of biological drugs and their patent expiration, the market has opened to biosimilar agents, copy versions of the originators, which can lead to reduced health care expenditure and increase treatment access worldwide. CT-P13 is the first biosimilar of infliximab (IFX) and has been approved for the same indications as its originator drug. It obtained regulatory approval by the European Medicines Agency in September 2013 and by the US Food and Drug Administration in April 2016. The Phase I and Phase III clinical trials conducted in ankylosing spondylitis and rheumatoid arthritis have demonstrated pharmacokinetic and efficacy equivalence with comparable safety and immunogenicity to IFX. For these reasons, the use of CT-P13 has been extrapolated also to inflammatory bowel disease. There have been some initial concerns regarding the use of CT-P13 in inflammatory bowel disease patients, because of the lack of randomized controlled trials. However, emerging real-world data have further confirmed the comparability between CT-P13 and its reference product in terms of efficacy, safety, and immunogenicity, in patients naïve to the anti-tumor necrosis factor alpha agents and after switching from IFX, and will be summarized in this review.

Biological Therapies in Immune-Mediated Inflammatory Diseases: Can Biosimilars Reduce Access Inequities?

“…There were also concerns about increased immunogenicity related to post-translational modification of the protein. However, data from real-world use have helped to confirm the similarity between CT-P13 and the reference product in terms of efficacy, safety and immunogenicity in IBD, although further studies on switching between products may be useful (e.g., cross-switching between biosimilars) (Gecse et al, 2016; Gabbani et al, 2017; Kurti et al, 2018).…”

Policy Options for Infliximab Biosimilars in Inflammatory Bowel Disease Given Emerging Evidence for Switching

“…Biosimilar infliximab (CT-P13, also known as Remsima™ and Inflectra™; SB2, also known as Flixabi TM ) is a large molecule (monoclonal antibody) that has gained marketing authorization in several jurisdictions for multiple indications including rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA), Crohn’s disease (CD) and ulcerative colitis (UC) [ 15 ]. Evidence provided to regulators included in vitro assay activity as well as comparative pharmacokinetics in patients with AS and comparative pharmacodynamic properties in patients with active RA treated with the originator product [ 15 ]. Assessments of safety and the development of neutralizing antibodies in RA and AS patients were also conducted [ 15 ].…”

“…Evidence provided to regulators included in vitro assay activity as well as comparative pharmacokinetics in patients with AS and comparative pharmacodynamic properties in patients with active RA treated with the originator product [ 15 ]. Assessments of safety and the development of neutralizing antibodies in RA and AS patients were also conducted [ 15 ].…”

The Future of Biosimilars: Maximizing Benefits Across Immune-Mediated Inflammatory Diseases

“…For extrapolation to be permitted, biosimilarity must have been demonstrated in in vitro, nonclinical, and clinical studies, and the rationale for extrapolation must be scientifically justifiable [3]. Today, approval of CT-P13 in IBD is also supported by real-world evidence and clinical trial data [34,[120][121][122][123], including from the randomized, double-blind, noninferiority phase IV NOR-SWITCH study [120] and a Hungarian prospective observational cohort study [124]. To our knowledge, no published clinical trials evaluating the approved adalimumab biosimilars ABP 501, BI 695501, or SB5 in IBD, or real-world evidence for other infliximab biosimilars exist.…”