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Current perspectives on biosimilars

In this work, an overview of the biosimilars market, pipeline and industry targets is discussed. Biosimilars typically have a shorter timeline for approval (8 years) compared to 12 years for innovator drugs and the development cost can be 10–20% of the innovator drug. The biosimilar pipeline is revi...

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Autores principales: Agbogbo, Frank K., Ecker, Dawn M., Farrand, Allison, Han, Kevin, Khoury, Antoine, Martin, Aaron, McCool, Jesse, Rasche, Ulrike, Rau, Tiffany D., Schmidt, David, Sha, Ma, Treuheit, Nicholas
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6791907/
https://www.ncbi.nlm.nih.gov/pubmed/31317293
http://dx.doi.org/10.1007/s10295-019-02216-z
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author Agbogbo, Frank K.
Ecker, Dawn M.
Farrand, Allison
Han, Kevin
Khoury, Antoine
Martin, Aaron
McCool, Jesse
Rasche, Ulrike
Rau, Tiffany D.
Schmidt, David
Sha, Ma
Treuheit, Nicholas
author_facet Agbogbo, Frank K.
Ecker, Dawn M.
Farrand, Allison
Han, Kevin
Khoury, Antoine
Martin, Aaron
McCool, Jesse
Rasche, Ulrike
Rau, Tiffany D.
Schmidt, David
Sha, Ma
Treuheit, Nicholas
author_sort Agbogbo, Frank K.
collection PubMed
description In this work, an overview of the biosimilars market, pipeline and industry targets is discussed. Biosimilars typically have a shorter timeline for approval (8 years) compared to 12 years for innovator drugs and the development cost can be 10–20% of the innovator drug. The biosimilar pipeline is reviewed as well as the quality management system (QMS) that is needed to generate traceable, trackable data sets. One difference between developing a biosimilar compared to an originator is that a broader analytical foundation is required for biosimilars and advances made in developing analytical similarity to characterize these products are discussed. An example is presented on the decisions and considerations explored in the development of a biosimilar and includes identification of the best process parameters and methods based on cost, time, and titer. Finally factors to consider in the manufacture of a biosimilar and approaches used to achieve the target-directed development of a biosimilar are discussed.
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spelling pubmed-67919072019-10-17 Current perspectives on biosimilars Agbogbo, Frank K. Ecker, Dawn M. Farrand, Allison Han, Kevin Khoury, Antoine Martin, Aaron McCool, Jesse Rasche, Ulrike Rau, Tiffany D. Schmidt, David Sha, Ma Treuheit, Nicholas J Ind Microbiol Biotechnol Fermentation, Cell Culture and Bioengineering - Review In this work, an overview of the biosimilars market, pipeline and industry targets is discussed. Biosimilars typically have a shorter timeline for approval (8 years) compared to 12 years for innovator drugs and the development cost can be 10–20% of the innovator drug. The biosimilar pipeline is reviewed as well as the quality management system (QMS) that is needed to generate traceable, trackable data sets. One difference between developing a biosimilar compared to an originator is that a broader analytical foundation is required for biosimilars and advances made in developing analytical similarity to characterize these products are discussed. An example is presented on the decisions and considerations explored in the development of a biosimilar and includes identification of the best process parameters and methods based on cost, time, and titer. Finally factors to consider in the manufacture of a biosimilar and approaches used to achieve the target-directed development of a biosimilar are discussed. Springer International Publishing 2019-07-17 2019 /pmc/articles/PMC6791907/ /pubmed/31317293 http://dx.doi.org/10.1007/s10295-019-02216-z Text en © The Author(s) 2019 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided 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 Fermentation, Cell Culture and Bioengineering - Review
Agbogbo, Frank K.
Ecker, Dawn M.
Farrand, Allison
Han, Kevin
Khoury, Antoine
Martin, Aaron
McCool, Jesse
Rasche, Ulrike
Rau, Tiffany D.
Schmidt, David
Sha, Ma
Treuheit, Nicholas
Current perspectives on biosimilars
title Current perspectives on biosimilars
title_full Current perspectives on biosimilars
title_fullStr Current perspectives on biosimilars
title_full_unstemmed Current perspectives on biosimilars
title_short Current perspectives on biosimilars
title_sort current perspectives on biosimilars
topic Fermentation, Cell Culture and Bioengineering - Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6791907/
https://www.ncbi.nlm.nih.gov/pubmed/31317293
http://dx.doi.org/10.1007/s10295-019-02216-z
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