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BioDrugs
Erschienen in: BioDrugs 5/2016

01.10.2016 | Adis Drug Evaluation

Infliximab Biosimilar (CT-P13; Infliximab-dyyb): A Review in Autoimmune Inflammatory Diseases

verfasst von: Hannah A. Blair, Emma D. Deeks

Erschienen in: BioDrugs | Ausgabe 5/2016

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Abstract

Infliximab biosimilar (CT-P13/infliximab-dyyb; Remsima®, Inflectra®) is approved in several countries for use in all indications for which reference infliximab (Remicade®) is approved, including rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis, psoriasis, Crohn’s disease, and ulcerative colitis. Clinical data contributing to the EU approval of infliximab biosimilar were obtained from two pivotal double-blind clinical trials in patients with AS (PLANETAS) or RA (PLANETRA). Infliximab biosimilar demonstrated equivalence to reference infliximab in terms of its pharmacokinetic profile in patients with AS, patients with RA, and in healthy volunteers, and in terms of its efficacy in patients with RA. Clinical response rates in patients with RA or AS were maintained over the longer term (up to 102 weeks). In addition, the efficacy of infliximab biosimilar in patients with RA or Crohn’s disease and ulcerative colitis [i.e. inflammatory bowel disease (IBD)] has been demonstrated in the real-world setting. Infliximab biosimilar was generally well tolerated, with a tolerability profile similar to that of reference infliximab. Switching from reference infliximab to infliximab biosimilar had no detrimental effect on efficacy, safety, or immunogenicity compared with continuous infliximab biosimilar therapy, according to the extensions of PLANETAS and PLANETRA, and real-world data in IBD. Current evidence therefore suggests that infliximab biosimilar is a useful alternative to reference infliximab in patients with autoimmune inflammatory diseases.
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Metadaten
Titel
Infliximab Biosimilar (CT-P13; Infliximab-dyyb): A Review in Autoimmune Inflammatory Diseases
verfasst von
Hannah A. Blair
Emma D. Deeks
Publikationsdatum
01.10.2016
Verlag
Springer International Publishing
Erschienen in
BioDrugs / Ausgabe 5/2016
Print ISSN: 1173-8804
Elektronische ISSN: 1179-190X
DOI
https://doi.org/10.1007/s40259-016-0193-2

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