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| 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. |
| 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... |
| Tipo: Journal article |
Palavras-chave: Bio therapeutic; Comparability; Critical quality attributes; Developing countries; Generics; Health policies; High quality biosimilars; Regulation. |
| Ano: 2016 |
URL: http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0717-34582016000600010 |
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