Literature DB >> 29172717

Comparative effectiveness of the biosimilar CT-P13.

Dae Hyun Yoo1.   

Abstract

The first biosimilar infliximab, CT-P13 (infliximab-dyyb) has been used for the treatment of inflammatory diseases for 4 years. CT-P13 has highly similar efficacy and safety profiles with a lower price than the originator infliximab and has been approved in 81 countries. Despite approval for clinical use, some knowledge gaps still limit the widespread and pertinent use of biosimilar CT-P13. One of the most important factors for proper utilization of CT-P13 for the treatment of immune-mediated inflammatory diseases is confidence in CT-P13, which could be enhanced by scientific evidence supporting the biosimilarity of CT-P13. Overall, five randomized controlled studies have been performed. For the other extrapolated indications, many observational induction and switching studies also support the utility of CT-P13 in the treatment of inflammatory diseases. Here, we review profiles of CT-P13 including physicochemical properties, clinical efficacy and safety data in all indications and current status.

Entities:  

Keywords:  CT-P13; ankylosing spondylitis; biosimilar; immunogenicity; inflammatory bowel disease; infliximab; rheumatoid arthritis; treatment

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Substances:

Year:  2017        PMID: 29172717     DOI: 10.2217/cer-2017-0033

Source DB:  PubMed          Journal:  J Comp Eff Res        ISSN: 2042-6305            Impact factor:   1.744


  2 in total

1.  Efficacy, pharmacokinetics and safety of subcutaneous versus intravenous CT-P13 in rheumatoid arthritis: a randomized phase I/III trial.

Authors:  Rene Westhovens; Piotr Wiland; Marek Zawadzki; Delina Ivanova; Alfredo Berrocal Kasay; Elias Chalouhi El-Khouri; Éva Balázs; Sergii Shevchuk; Larisa Eliseeva; Mykola Stanislavchuk; Roman Yatsyshyn; Paweł Hrycaj; Janusz Jaworski; Vyacheslav Zhdan; Jakub Trefler; Pavel Shesternya; Sang Joon Lee; Sung Hyun Kim; Jee Hye Suh; Seul Gi Lee; Noo Ri Han; Dae Hyun Yoo
Journal:  Rheumatology (Oxford)       Date:  2021-05-14       Impact factor: 7.580

2.  An Efficient Development Paradigm for Biosimilars.

Authors:  Christopher J Webster; Anny C Wong; Gillian R Woollett
Journal:  BioDrugs       Date:  2019-12       Impact factor: 5.807

  2 in total

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