Pan American Journal of Public Health Publishes Letter from Professor Lietzan

The Pan American Journal of Public Health published a letter from Professor Erika Lietzan, in which she responds to an article about Colombia’s pathways for approval of biosimilar biologics.

A 2014 presidential decree in Colombia allowed for three pathways to market for biologics, and the earlier article, written by the country’s Minister of Health and Social Protection and his colleagues, stated that Colombia’s approach follows a global trend and was consistent with the European and U.S. approaches.

Professor Lietzan explains that the authors mischaracterize U.S. and European requirements for biosimilar biologics and that the three-pathway approach in Colombia actually differs fundamentally from those approaches. In response, the authors concede Professor Lietzan’s description of U.S. and European law, and generally agree that the Colombian approach is “innovative.”