3rd Colombian educational workshop on regulatory assessment of biosimilars 2019 – Report

Author byline as per print journal: Professor John-Joseph Borg, PhD; Yolanda Elias Gramajo, MD; Professor Andrea Laslop, MD; Robin Thorpe, PhD, FRCPath; Jian Wang, MD, PhD Introduction: Biosimilars have the potential to improve access to medicines for many across the globe. However, work is required to ensure adequate regulation, pharmacovigilance and education about biosimilars. Colombia […]


Regulations for biotherapeutics approval in Colombia

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 […]