GENERICS AND BIOSIMILARS INITIATIVE JOURNAL
Official Journal of the Generics and Biosimilars Initiative

Volume 7 / Year 2018 / Issue 1

Regulatory

Regulations for biotherapeutics approval in Colombia

Author(s): Francisco Javier Sierra Esteban, MSc, Johanna Andrea García Cortes, MSc

Page: 26-8

Author byline as per print journal: Johanna Andrea García Cortes, MSc; Francisco Javier Sierra Esteban, MSc Abstract: Colombia is in the process of implementing legislation to allow for the approval of biosimilar products so that they can enter the Colombian market. Three regulatory pathways for the submission of biotherapeutic products have been developed and were […]

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Last update: 27/03/2018

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