Waiving in vivo studies for monoclonal antibody biosimilar development: National and global challenges

Biosimilars are biological medicinal products that contain a version of the active substance of an already authorised original biological medicinal product (the innovator or reference product). The first approved biosimilar medicines were small proteins, and more recently biosimilar versions of inno...

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Main Authors:	Chapman, Kathryn, Adjei, Akosua, Baldrick, Paul, da Silva, Antonio, De Smet, Karen, DiCicco, Richard, Hong, Seung Suh, Jones, David, Leach, Michael W., McBlane, James, Ragan, Ian, Reddy, Praveen, Stewart, Donald I. H., Suitters, Amanda, Sims, Jennifer
Format:	Online
Language:	English
Published:	Taylor & Francis 2016
Online Access:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4966840/

id	pubmed-4966840
recordtype	oai_dc
spelling	pubmed-49668402016-08-23 Waiving in vivo studies for monoclonal antibody biosimilar development: National and global challenges Chapman, Kathryn Adjei, Akosua Baldrick, Paul da Silva, Antonio De Smet, Karen DiCicco, Richard Hong, Seung Suh Jones, David Leach, Michael W. McBlane, James Ragan, Ian Reddy, Praveen Stewart, Donald I. H. Suitters, Amanda Sims, Jennifer Perspective Biosimilars are biological medicinal products that contain a version of the active substance of an already authorised original biological medicinal product (the innovator or reference product). The first approved biosimilar medicines were small proteins, and more recently biosimilar versions of innovator monoclonal antibody (mAb) drugs have entered development as patents on these more complex proteins expire. In September 2013, the first biosimilar mAb, infliximab, was authorised in Europe. In March 2015, the first biosimilar (Zarxio™, filgrastim-sndz, Sandoz) was approved by the US Food and Drug Administration; however, to date no mAb biosimilars have been approved in the US. There are currently major differences between how biosimilars are regulated in different parts of the world, leading to substantial variability in the amount of in vivo nonclinical toxicity testing required to support clinical development and marketing of biosimilars. There are approximately 30 national and international guidelines on biosimilar development and this number is growing. The European Union's guidance describes an approach that enables biosimilars to enter clinical trials based on robust in vitro data alone; in contrast, the World Health Organization's guidance is interpreted globally to mean in vivo toxicity studies are mandatory. Taylor & Francis 2016-02-06 /pmc/articles/PMC4966840/ /pubmed/26854177 http://dx.doi.org/10.1080/19420862.2016.1145331 Text en © 2016 The Author(s). Published with license by Taylor & Francis Group, LLC http://creativecommons.org/licenses/by-nc/3.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution-Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/), which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. The moral rights of the named author(s) have been asserted.
repository_type	Open Access Journal
institution_category	Foreign Institution
institution	US National Center for Biotechnology Information
building	NCBI PubMed
collection	Online Access
language	English
format	Online
author	Chapman, Kathryn Adjei, Akosua Baldrick, Paul da Silva, Antonio De Smet, Karen DiCicco, Richard Hong, Seung Suh Jones, David Leach, Michael W. McBlane, James Ragan, Ian Reddy, Praveen Stewart, Donald I. H. Suitters, Amanda Sims, Jennifer
spellingShingle	Chapman, Kathryn Adjei, Akosua Baldrick, Paul da Silva, Antonio De Smet, Karen DiCicco, Richard Hong, Seung Suh Jones, David Leach, Michael W. McBlane, James Ragan, Ian Reddy, Praveen Stewart, Donald I. H. Suitters, Amanda Sims, Jennifer Waiving in vivo studies for monoclonal antibody biosimilar development: National and global challenges
author_facet	Chapman, Kathryn Adjei, Akosua Baldrick, Paul da Silva, Antonio De Smet, Karen DiCicco, Richard Hong, Seung Suh Jones, David Leach, Michael W. McBlane, James Ragan, Ian Reddy, Praveen Stewart, Donald I. H. Suitters, Amanda Sims, Jennifer
author_sort	Chapman, Kathryn
title	Waiving in vivo studies for monoclonal antibody biosimilar development: National and global challenges
title_short	Waiving in vivo studies for monoclonal antibody biosimilar development: National and global challenges
title_full	Waiving in vivo studies for monoclonal antibody biosimilar development: National and global challenges
title_fullStr	Waiving in vivo studies for monoclonal antibody biosimilar development: National and global challenges
title_full_unstemmed	Waiving in vivo studies for monoclonal antibody biosimilar development: National and global challenges
title_sort	waiving in vivo studies for monoclonal antibody biosimilar development: national and global challenges
description	Biosimilars are biological medicinal products that contain a version of the active substance of an already authorised original biological medicinal product (the innovator or reference product). The first approved biosimilar medicines were small proteins, and more recently biosimilar versions of innovator monoclonal antibody (mAb) drugs have entered development as patents on these more complex proteins expire. In September 2013, the first biosimilar mAb, infliximab, was authorised in Europe. In March 2015, the first biosimilar (Zarxio™, filgrastim-sndz, Sandoz) was approved by the US Food and Drug Administration; however, to date no mAb biosimilars have been approved in the US. There are currently major differences between how biosimilars are regulated in different parts of the world, leading to substantial variability in the amount of in vivo nonclinical toxicity testing required to support clinical development and marketing of biosimilars. There are approximately 30 national and international guidelines on biosimilar development and this number is growing. The European Union's guidance describes an approach that enables biosimilars to enter clinical trials based on robust in vitro data alone; in contrast, the World Health Organization's guidance is interpreted globally to mean in vivo toxicity studies are mandatory.
publisher	Taylor & Francis
publishDate	2016
url	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4966840/
_version_	1613617964824657920

Waiving in vivo studies for monoclonal antibody biosimilar development: National and global challenges

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