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Approval of the first biosimilar antibodies in Europe: A major landmark for the biopharmaceutical industry

In a defining moment for the European Medicines Agency (EMA) and the biopharmaceutical industry, on June 27, 2013 EMA’s Committee for Medicinal Products for Human Use adopted a positive opinion for two biosimilar infliximab products (Celltrion’s Remsima® and Hospira’s Inflectra®), and recommended th...

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Autores principales: Beck, Alain, Reichert, Janice M.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Landes Bioscience 2013
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3851211/
https://www.ncbi.nlm.nih.gov/pubmed/23924791
http://dx.doi.org/10.4161/mabs.25864
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author Beck, Alain
Reichert, Janice M.
author_facet Beck, Alain
Reichert, Janice M.
author_sort Beck, Alain
collection PubMed
description In a defining moment for the European Medicines Agency (EMA) and the biopharmaceutical industry, on June 27, 2013 EMA’s Committee for Medicinal Products for Human Use adopted a positive opinion for two biosimilar infliximab products (Celltrion’s Remsima® and Hospira’s Inflectra®), and recommended that they be approved for marketing in the European Union (EU). The European Commission’s decision on an application is typically issued 67 d after an opinion is provided; thus, decisions are expected in early September 2013. If approved, the products will comprise the first biosimilar antibody made available to patients in a highly regulated market, although launch may be delayed due to an extension of the reference product’s (Remicade®) patent in the EU.
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spelling pubmed-38512112013-12-31 Approval of the first biosimilar antibodies in Europe: A major landmark for the biopharmaceutical industry Beck, Alain Reichert, Janice M. MAbs Editorial In a defining moment for the European Medicines Agency (EMA) and the biopharmaceutical industry, on June 27, 2013 EMA’s Committee for Medicinal Products for Human Use adopted a positive opinion for two biosimilar infliximab products (Celltrion’s Remsima® and Hospira’s Inflectra®), and recommended that they be approved for marketing in the European Union (EU). The European Commission’s decision on an application is typically issued 67 d after an opinion is provided; thus, decisions are expected in early September 2013. If approved, the products will comprise the first biosimilar antibody made available to patients in a highly regulated market, although launch may be delayed due to an extension of the reference product’s (Remicade®) patent in the EU. Landes Bioscience 2013-09-01 2013-07-24 /pmc/articles/PMC3851211/ /pubmed/23924791 http://dx.doi.org/10.4161/mabs.25864 Text en Copyright © 2013 Landes Bioscience http://creativecommons.org/licenses/by-nc/3.0/ This is an open-access article licensed under a Creative Commons Attribution-NonCommercial 3.0 Unported License. The article may be redistributed, reproduced, and reused for non-commercial purposes, provided the original source is properly cited.
spellingShingle Editorial
Beck, Alain
Reichert, Janice M.
Approval of the first biosimilar antibodies in Europe: A major landmark for the biopharmaceutical industry
title Approval of the first biosimilar antibodies in Europe: A major landmark for the biopharmaceutical industry
title_full Approval of the first biosimilar antibodies in Europe: A major landmark for the biopharmaceutical industry
title_fullStr Approval of the first biosimilar antibodies in Europe: A major landmark for the biopharmaceutical industry
title_full_unstemmed Approval of the first biosimilar antibodies in Europe: A major landmark for the biopharmaceutical industry
title_short Approval of the first biosimilar antibodies in Europe: A major landmark for the biopharmaceutical industry
title_sort approval of the first biosimilar antibodies in europe: a major landmark for the biopharmaceutical industry
topic Editorial
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3851211/
https://www.ncbi.nlm.nih.gov/pubmed/23924791
http://dx.doi.org/10.4161/mabs.25864
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