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PF-06438179/GP1111: An Infliximab Biosimilar
PF-06438179/GP1111 (Zessly(®); Ixifi(®)) [hereafter referred to as GP1111] is a biosimilar of the reference monoclonal anti-TNF-α antibody infliximab, and is approved in the EU and USA for the same indications as the reference drug, including rheumatoid arthritis (RA), Crohn’s disease, ulcerative co...
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Springer International Publishing
2018
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6290860/ https://www.ncbi.nlm.nih.gov/pubmed/30284704 http://dx.doi.org/10.1007/s40259-018-0310-5 |
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author | Al-Salama, Zaina T. |
author_facet | Al-Salama, Zaina T. |
author_sort | Al-Salama, Zaina T. |
collection | PubMed |
description | PF-06438179/GP1111 (Zessly(®); Ixifi(®)) [hereafter referred to as GP1111] is a biosimilar of the reference monoclonal anti-TNF-α antibody infliximab, and is approved in the EU and USA for the same indications as the reference drug, including rheumatoid arthritis (RA), Crohn’s disease, ulcerative colitis (including paediatric ulcerative colitis in the EU), ankylosing spondylitis, psoriatic arthritis and plaque psoriasis; GP1111 is also approved in Japan. GP1111 has similar physicochemical characteristics and pharmacodynamic properties to those of reference infliximab, and the pharmacokinetic similarity of the agents has been shown in healthy volunteers and patients with moderate-to-severe RA despite methotrexate therapy. GP1111 demonstrated clinical efficacy equivalent to that of reference infliximab in patients with moderate-to-severe RA, despite methotrexate therapy, and was generally well tolerated in this population. The tolerability, immunogenicity and safety profiles of GP1111 were similar to those of reference infliximab, and switching from reference infliximab to GP1111 had no impact on safety, efficacy or immunogenicity. The role of reference infliximab in the management of autoimmune inflammatory conditions is well established and GP1111 provides an effective biosimilar alternative for patients requiring infliximab therapy. |
format | Online Article Text |
id | pubmed-6290860 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | Springer International Publishing |
record_format | MEDLINE/PubMed |
spelling | pubmed-62908602018-12-27 PF-06438179/GP1111: An Infliximab Biosimilar Al-Salama, Zaina T. BioDrugs Adis Biosimilar Brief PF-06438179/GP1111 (Zessly(®); Ixifi(®)) [hereafter referred to as GP1111] is a biosimilar of the reference monoclonal anti-TNF-α antibody infliximab, and is approved in the EU and USA for the same indications as the reference drug, including rheumatoid arthritis (RA), Crohn’s disease, ulcerative colitis (including paediatric ulcerative colitis in the EU), ankylosing spondylitis, psoriatic arthritis and plaque psoriasis; GP1111 is also approved in Japan. GP1111 has similar physicochemical characteristics and pharmacodynamic properties to those of reference infliximab, and the pharmacokinetic similarity of the agents has been shown in healthy volunteers and patients with moderate-to-severe RA despite methotrexate therapy. GP1111 demonstrated clinical efficacy equivalent to that of reference infliximab in patients with moderate-to-severe RA, despite methotrexate therapy, and was generally well tolerated in this population. The tolerability, immunogenicity and safety profiles of GP1111 were similar to those of reference infliximab, and switching from reference infliximab to GP1111 had no impact on safety, efficacy or immunogenicity. The role of reference infliximab in the management of autoimmune inflammatory conditions is well established and GP1111 provides an effective biosimilar alternative for patients requiring infliximab therapy. Springer International Publishing 2018-10-04 2018 /pmc/articles/PMC6290860/ /pubmed/30284704 http://dx.doi.org/10.1007/s40259-018-0310-5 Text en © Springer Nature 2018, corrected publication November/2018 Open AccessThis article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/), which permits any noncommercial use, duplication, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license and indicate if changes were made. |
spellingShingle | Adis Biosimilar Brief Al-Salama, Zaina T. PF-06438179/GP1111: An Infliximab Biosimilar |
title | PF-06438179/GP1111: An Infliximab Biosimilar |
title_full | PF-06438179/GP1111: An Infliximab Biosimilar |
title_fullStr | PF-06438179/GP1111: An Infliximab Biosimilar |
title_full_unstemmed | PF-06438179/GP1111: An Infliximab Biosimilar |
title_short | PF-06438179/GP1111: An Infliximab Biosimilar |
title_sort | pf-06438179/gp1111: an infliximab biosimilar |
topic | Adis Biosimilar Brief |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6290860/ https://www.ncbi.nlm.nih.gov/pubmed/30284704 http://dx.doi.org/10.1007/s40259-018-0310-5 |
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