Characterization and comparability of biosimilars: A filgrastim case of study and regulatory perspectives for Latin America

Background: Developing countries have an estimate of ten times more approved biosimilars than developed countries. This disparity demands the need of an objective regulation that incorporates health policies according to the technological and economical capabilities of each country. One of the chall...

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Autores principales:	Mendoza-Macedo,Karina, Romero-Díaz,Alexis J, Miranda-Hernández,Mariana P, Campos-García,Víctor R, Ramírez-Ibañez,Nancy D, Juárez-Bayardo,L. Carmina, Moreno-Duran,Karen, Cedillo-Robles,Miriam S, Pérez,Nestor O, Jung-Cook,Helgi, Flores-Ortiz,Luis F, Medina-Rivero,Emilio
Lenguaje:	English
Publicado:	Pontificia Universidad Católica de Valparaíso 2016
Materias:	Bio therapeutic Comparability Critical quality attributes Developing countries Generics Health policies High quality biosimilars Regulation
Acceso en línea:	http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0717-34582016000600010
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spelling	oai:scielo:S0717-345820160006000102017-01-25Characterization and comparability of biosimilars: A filgrastim case of study and regulatory perspectives for Latin AmericaMendoza-Macedo,KarinaRomero-Díaz,Alexis JMiranda-Hernández,Mariana PCampos-García,Víctor RRamírez-Ibañez,Nancy DJuárez-Bayardo,L. CarminaMoreno-Duran,KarenCedillo-Robles,Miriam SPérez,Nestor OJung-Cook,HelgiFlores-Ortiz,Luis FMedina-Rivero,Emilio Bio therapeutic Comparability Critical quality attributes Developing countries Generics Health policies High quality biosimilars Regulation Background: Developing countries have an estimate of ten times more approved biosimilars than developed countries. This disparity demands the need of an objective regulation that incorporates health policies according to the technological and economical capabilities of each country. One of the challenges lies on the establishment of comparability principles based on a physicochemical and biological characterization that should determine the extent of additional non-clinical and clinical studies. This is particularly relevant for licensed biosimilars in developing countries, which have an extensive clinical experience since their approval as generics' in some cases more than a decade. To exemplify the current status of biosimilars in Mexico' a characterization exercise was conducted on licensed filgrastim biosimilars using pharmacopeial and extended characterization methodologies. Results: Most of the evaluated products complied with the pharmacopeial criteria and showed comparability in their Critical Quality Attributes (CQAs) towards the reference product. These results were expected in accordance with their equivalent performance during their licensing as generics. Accordingly' a rational approval and registration renewal scheme for biosimilars is proposed, that considers the proper identification of CQAs and its thoroughly evaluation using selected techniques. Conclusions: This approach provides support to diminish uncertainty of exhibiting different pharmacological profiles and narrows or even avoids the necessity of comparative clinical studies. Ultimately, this proposal is intended to improve the accessibility to high quality biosimilars in Latin America and other developing countries.info:eu-repo/semantics/openAccessPontificia Universidad Católica de ValparaísoElectronic Journal of Biotechnology v.19 n.6 20162016-11-01text/htmlhttp://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0717-34582016000600010en10.1016/j.ejbt.2016.10.003
institution	Scielo Chile
collection	Scielo Chile
language	English
topic	Bio therapeutic Comparability Critical quality attributes Developing countries Generics Health policies High quality biosimilars Regulation
spellingShingle	Bio therapeutic Comparability Critical quality attributes Developing countries Generics Health policies High quality biosimilars Regulation Mendoza-Macedo,Karina Romero-Díaz,Alexis J Miranda-Hernández,Mariana P Campos-García,Víctor R Ramírez-Ibañez,Nancy D Juárez-Bayardo,L. Carmina Moreno-Duran,Karen Cedillo-Robles,Miriam S Pérez,Nestor O Jung-Cook,Helgi Flores-Ortiz,Luis F Medina-Rivero,Emilio Characterization and comparability of biosimilars: A filgrastim case of study and regulatory perspectives for Latin America
description	Background: Developing countries have an estimate of ten times more approved biosimilars than developed countries. This disparity demands the need of an objective regulation that incorporates health policies according to the technological and economical capabilities of each country. One of the challenges lies on the establishment of comparability principles based on a physicochemical and biological characterization that should determine the extent of additional non-clinical and clinical studies. This is particularly relevant for licensed biosimilars in developing countries, which have an extensive clinical experience since their approval as generics' in some cases more than a decade. To exemplify the current status of biosimilars in Mexico' a characterization exercise was conducted on licensed filgrastim biosimilars using pharmacopeial and extended characterization methodologies. Results: Most of the evaluated products complied with the pharmacopeial criteria and showed comparability in their Critical Quality Attributes (CQAs) towards the reference product. These results were expected in accordance with their equivalent performance during their licensing as generics. Accordingly' a rational approval and registration renewal scheme for biosimilars is proposed, that considers the proper identification of CQAs and its thoroughly evaluation using selected techniques. Conclusions: This approach provides support to diminish uncertainty of exhibiting different pharmacological profiles and narrows or even avoids the necessity of comparative clinical studies. Ultimately, this proposal is intended to improve the accessibility to high quality biosimilars in Latin America and other developing countries.
author	Mendoza-Macedo,Karina Romero-Díaz,Alexis J Miranda-Hernández,Mariana P Campos-García,Víctor R Ramírez-Ibañez,Nancy D Juárez-Bayardo,L. Carmina Moreno-Duran,Karen Cedillo-Robles,Miriam S Pérez,Nestor O Jung-Cook,Helgi Flores-Ortiz,Luis F Medina-Rivero,Emilio
author_facet	Mendoza-Macedo,Karina Romero-Díaz,Alexis J Miranda-Hernández,Mariana P Campos-García,Víctor R Ramírez-Ibañez,Nancy D Juárez-Bayardo,L. Carmina Moreno-Duran,Karen Cedillo-Robles,Miriam S Pérez,Nestor O Jung-Cook,Helgi Flores-Ortiz,Luis F Medina-Rivero,Emilio
author_sort	Mendoza-Macedo,Karina
title	Characterization and comparability of biosimilars: A filgrastim case of study and regulatory perspectives for Latin America
title_short	Characterization and comparability of biosimilars: A filgrastim case of study and regulatory perspectives for Latin America
title_full	Characterization and comparability of biosimilars: A filgrastim case of study and regulatory perspectives for Latin America
title_fullStr	Characterization and comparability of biosimilars: A filgrastim case of study and regulatory perspectives for Latin America
title_full_unstemmed	Characterization and comparability of biosimilars: A filgrastim case of study and regulatory perspectives for Latin America
title_sort	characterization and comparability of biosimilars: a filgrastim case of study and regulatory perspectives for latin america
publisher	Pontificia Universidad Católica de Valparaíso
publishDate	2016
url	http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0717-34582016000600010
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Characterization and comparability of biosimilars: A filgrastim case of study and regulatory perspectives for Latin America

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