Toward interchangeable biologics

A biosimilar is designed to match the reference product – to be as close to the reference as the reference is to itself considering batch‐to‐batch variability and manufacturing changes over its lifetime.(1) Interchangeability will require additional data, however, the interchangeable biologic itself...

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Detalles Bibliográficos
Autores principales: McCamish, M, Pakulski, J, Sattler, C, Woollett, G
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2015
Materias:
Developments
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6706804/
https://www.ncbi.nlm.nih.gov/pubmed/25670498
http://dx.doi.org/10.1002/cpt.39
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author McCamish, M
Pakulski, J
Sattler, C
Woollett, G
author_facet McCamish, M
Pakulski, J
Sattler, C
Woollett, G
author_sort McCamish, M
collection PubMed
description A biosimilar is designed to match the reference product – to be as close to the reference as the reference is to itself considering batch‐to‐batch variability and manufacturing changes over its lifetime.(1) Interchangeability will require additional data, however, the interchangeable biologic itself will be the same as that approved for biosimilarity.
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spelling pubmed-67068042019-08-28 Toward interchangeable biologics McCamish, M Pakulski, J Sattler, C Woollett, G Clin Pharmacol Ther Developments A biosimilar is designed to match the reference product – to be as close to the reference as the reference is to itself considering batch‐to‐batch variability and manufacturing changes over its lifetime.(1) Interchangeability will require additional data, however, the interchangeable biologic itself will be the same as that approved for biosimilarity. John Wiley and Sons Inc. 2015-01-21 2015-03 /pmc/articles/PMC6706804/ /pubmed/25670498 http://dx.doi.org/10.1002/cpt.39 Text en © 2015 The Authors. Clinical Pharmacology & Therapeutics published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
spellingShingle Developments
McCamish, M
Pakulski, J
Sattler, C
Woollett, G
Toward interchangeable biologics
title Toward interchangeable biologics
title_full Toward interchangeable biologics
title_fullStr Toward interchangeable biologics
title_full_unstemmed Toward interchangeable biologics
title_short Toward interchangeable biologics
title_sort toward interchangeable biologics
topic Developments
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6706804/
https://www.ncbi.nlm.nih.gov/pubmed/25670498
http://dx.doi.org/10.1002/cpt.39
work_keys_str_mv AT mccamishm towardinterchangeablebiologics
AT pakulskij towardinterchangeablebiologics
AT sattlerc towardinterchangeablebiologics
AT woollettg towardinterchangeablebiologics

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