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

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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Bibliographic Details
Main Authors: Karina Mendoza-Macedo, Alexis J. Romero-Díaz, Mariana P. Miranda-Hernández, Víctor R. Campos-García, Nancy D. Ramírez-Ibañez, L. Carmina Juárez-Bayardo, Karen Moreno-Duran, Miriam S. Cedillo-Robles, Nestor O. Pérez, Helgi Jung-Cook, Luis F. Flores-Ortiz, Emilio Medina-Rivero
Format: Article
Language:English
Published: Elsevier 2016-11-01
Series:Electronic Journal of Biotechnology
Subjects:
Bio therapeutic
Comparability
Critical quality attributes
Developing countries
Generics
Health policies
High quality biosimilars
Regulation
Online Access:http://www.sciencedirect.com/science/article/pii/S0717345816300987

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http://www.sciencedirect.com/science/article/pii/S0717345816300987

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