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

Tommaso Gabbani1, Simona Deiana2, Vito Annese3

  • 1Gastroenterology Unit, Morgagni-Pierantoni Hospital, AUSL Romagna, Forlì.

Drug Design, Development and Therapy
|June 28, 2017
PubMed
Summary

Biosimilar infliximab (CT-P13) offers comparable efficacy and safety to the original biologic for immune-mediated diseases. Real-world data support its use in inflammatory bowel disease, increasing treatment access.

Keywords:
CT-P13Crohn’s diseasebiologic therapybiosimilarinfliximabulcerative colitis

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Area of Science:

  • Immunology
  • Pharmacology
  • Gastroenterology

Background:

  • Biological agents have transformed immune-mediated disease treatment.
  • Biosimilars, like CT-P13 (infliximab biosimilar), offer cost savings and wider access.
  • CT-P13 is approved for indications matching its originator, infliximab (IFX).

Purpose of the Study:

  • To review the efficacy, safety, and immunogenicity of CT-P13 in inflammatory bowel disease (IBD).
  • To address concerns regarding CT-P13 use in IBD due to limited randomized controlled trials.
  • To summarize emerging real-world data supporting CT-P13 comparability to IFX.

Main Methods:

  • Review of clinical trial data (Phase I and III) in ankylosing spondylitis and rheumatoid arthritis.
  • Analysis of emerging real-world evidence in inflammatory bowel disease patients.
  • Comparison of CT-P13 with originator infliximab (IFX) regarding pharmacokinetics, efficacy, safety, and immunogenicity.

Main Results:

  • Phase I and III trials demonstrated pharmacokinetic and efficacy equivalence between CT-P13 and IFX.
  • Real-world data confirm comparable efficacy, safety, and immunogenicity of CT-P13 versus IFX.
  • Comparisons were made in both anti-tumor necrosis factor alpha-naïve patients and those switching from IFX.

Conclusions:

  • CT-P13 is a viable biosimilar to infliximab for immune-mediated diseases, including IBD.
  • Real-world data validate the extrapolation of CT-P13's efficacy and safety to IBD patients.
  • CT-P13 expands treatment options and potentially reduces healthcare costs for IBD management.