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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Détails bibliographiques
Auteurs principaux: 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
Langue:English
Publié: Pontificia Universidad Católica de Valparaíso 2016
Sujets:
Bio therapeutic
Comparability
Critical quality attributes
Developing countries
Generics
Health policies
High quality biosimilars
Regulation
Accès en ligne:http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0717-34582016000600010
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