Row Erupts Over “Third Way” For Biosimilar Approvals In Colombia

Colombia’s health ministry has accused the R&D-based pharmaceutical industry association of prioritizing monopolies over patients after its attempts to suspend legislation that promises a faster route to market for biosimilars.

Medicine
A row erupts in Colombia over approval pathways for biosimilars • Source: Shutterstock

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...

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