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In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
Published on: May 4, 2017
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Comparative effectiveness of the biosimilar CT-P13
1Department of Rheumatology, College of Medicine, Hanyang University Hospital for Rheumatic Diseases, Hanyang University, 222-1 Wangsimni-ro Seongdong-gu, Seoul, 04763, Korea.
Journal of Comparative Effectiveness Research
|November 28, 2017
Summary
The biosimilar infliximab CT-P13 (infliximab-dyyb) shows similar efficacy and safety to the original drug. Extensive studies support its use in inflammatory diseases, enhancing confidence in this lower-cost treatment option.
Area of Science:
- Immunology
- Pharmacology
- Rheumatology
Background:
- The first biosimilar infliximab, CT-P13 (infliximab-dyyb), has been available for four years.
- It demonstrates comparable efficacy and safety to originator infliximab at a reduced cost and is approved in 81 countries.
- Knowledge gaps persist, potentially limiting its widespread adoption for immune-mediated inflammatory diseases.
Purpose of the Study:
- To review the physicochemical properties, clinical efficacy, and safety data of CT-P13.
- To consolidate scientific evidence supporting the biosimilarity of CT-P13.
- To address knowledge gaps and enhance confidence in the utilization of CT-P13.
Main Methods:
- Review of five randomized controlled studies.
- Analysis of observational induction and switching studies for extrapolated indications.
- Compilation of data on physicochemical properties, clinical efficacy, and safety.
Main Results:
- CT-P13 exhibits highly similar efficacy and safety profiles to originator infliximab.
- Evidence from multiple study types supports its utility across various inflammatory disease indications.
- The biosimilar has demonstrated a favorable benefit-risk profile.
Conclusions:
- CT-P13 is a well-established biosimilar with robust scientific evidence supporting its clinical use.
- Confidence in CT-P13 can be enhanced through continued dissemination of efficacy and safety data.
- The biosimilar offers a valuable, cost-effective treatment option for inflammatory diseases.
Keywords:
CT-P13ankylosing spondylitisbiosimilarimmunogenicityinflammatory bowel diseaseinfliximabrheumatoid arthritistreatmentMore Related Videos
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