How Colombia’s biosimilar regulation departs from international norms

Abstract

Dear editor I write in response to an article published in January 2016 regarding Colombia’s 2014 regulation governing registration of biosimilar biological products (1). In my view, the article seriously misstates international norms regarding approval of biosimilars and creates a misimpression that the new Colombian regime is consistent with the approach taken in Europe and the United States. In fact, the Colombian regulation departs significantly from international norms. Generally speaking, the consensus approach in the rest of the world involves two pathways to market for biological medicines: a full dossier with robust preclinical and clinical evidence of safety and effectiveness, and an abbreviated dossier with a robust showing of similarity to an originator product sufficient to justify reliance on the originator’s safety and effectiveness research. There is no third pathway. The consensus approach to the abbreviated dossier for a biological medicine involves a rigorous comparison of the proposed medicine with a single originator product, proceeding step-by-step through comparative analytical and functional characterization to preclinical testing and clinical testing. Clinical data are always required...