Klin Farmakol Farm. 2014;28(1):19-22

First biosimilar monoclonal antibody introduced to clinical praxis: infliximab

Karel Urbánek
Ústav farmakologie Lékařské fakulty Univerzity Palackého a Fakultní nemocnice Olomouc

Infliximab CT-P13 is the first monoclonal antibody that has been tested in accordance with the European Medicines Agency for biosimilars

and also has been approved. The article summarizes the results of preclinical and clinical evaluation of this particular substance and its

comparison with the original product.

Keywords: biosimilar, infliximab, CT-P13, efficacy, safety, indications

Published: March 1, 2014  Show citation

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Urbánek K. First biosimilar monoclonal antibody introduced to clinical praxis: infliximab. Klin Farmakol Farm. 2014;28(1):19-22.
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    References

    1. Park W, Hrycaj P, Jeka S, et al. A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety and efficacyof CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study. Ann Rheum Dis. 2013; 72 (10): 1605-1612. Go to original source... Go to PubMed...
    2. Yoo DH, Hrycaj P, Miranda P, et al. A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safetyof CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study. Ann Rheum Dis. 2013; 72 (10): 1613-1620. Go to original source... Go to PubMed...
    3. Yoo DH, Yagensky A, Toncheva A, et al. Impactof CT-P13 and Originator Infliximab Treatment on Quality of Life Derived from the Health Assessment Questionnaire (HAQ) and Short-form 36 (SF-36) from a Randomized, Double-Blind Trial in Patients with Active RA. Poster na 13th ACR/ARHP Annual Meeting, San Diego 2013. Abstrakt dostupný na http://acrannualmeeting.org/Abstracts.
    4. Park W, Miranda P, Brzosko M, et al. Efficacy and Safety of CT-P13 (infliximab biosimilar) over Two Years in Patients with Ankylosing Spondylitis: Comparison Between Continuing with CT-P13 and Switching from Infliximab to CT-P13. Poster na 13th ACR/ARHP Annual Meeting, San Diego 2013. Abstrakt dostupný na http://acrannualmeeting.org/Abstracts.
    5. Yoo DH, Prodanovic N, Jaworski J, et al. Efficacy and Safety of CT-P13 (Infliximab biosimilar) over Two Years in Patients with Rheumatoid Arthritis: Comparison Between Continued CT-P13 and Switching from Infliximab to CT-P13. Přednáška na 13th ACR/ARHP Annual Meeting, San Diego 2013. Abstrakt dostupný na https://ww2.rheumatology.org/apps/MyAnnualMeeting/Abstract/39033.
    6. SPC přípravku Remsima. Dostupné na ww.sukl.cz.

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