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EDITORIAL ARTICLE
Biosymilars in the treatment of rheumatic diseases
Online publication date: 2013-12-24
Reumatologia 2013;51(6):399-408
KEYWORDS
ABSTRACT
The availability of biosimilar versions of biopharmaceuticals with comparative efficacy and safety but at a lower cost may increase the number of patients treated with biological agents. CT-P13 is a biosimilar infliximab that was compared to innovator infliximab in two clinical trials to assess its potential non-inferiority to the reference product according to the EMA guidelines. The PLANETRA trial was a phase III study that evaluated the efficacy and safety of CT-P13 compared to infliximab in combination with methotrexate in 602 patients with active rheumatoid arthritis. The PLANETAS trial was a phase I study that compared the pharmacokinetics, efficacy and safety of both agents as monotherapy in 250 patients with ankylosing spondylitis. Both studies are the first clinical trials to demonstrate unequivocal efficacy and safety of a biosimilar for the treatment.
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Copyright: © Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji w Warszawie. This is an Open Access journal, all articles are distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International (CC BY-NC-SA 4.0) License (https://creativecommons.org/licenses/by-nc-sa/4.0/), allowing third parties to copy and redistribute the material in any medium or format and to remix, transform, and build upon the material, provided the original work is properly cited and states its license.
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