Colombia’s health ministry and the international R&D-based pharmaceutical industry association, Afidro, are at loggerheads over legislation that gives biosimilars a faster route to market. Afidro has requested that a decree be suspended, claiming that it will lead to the approval of medicines that have not been properly tested. Meanwhile, the health ministry has accused the association of creating overly onerous barriers to competition.
The legislation in question is Decree 1782 of 2014, which seeks to establish the procedures and requirements for evaluating and registering biological medicines. It sets out three possible pathways for...