Colombia: Council of State approves “biosimilar” market entry using alternative way

In September 2014, the government of Colombia issued decree 1782 which would allow the entry of biosimilars to the country, i.e., the biotech “generics”.

The decree caused quite a controversy in the pharmaceutical sector, reason why Afidro filed a lawsuit before the Council of State in 2016, with the aim of imposing a precautionary measure and not allowing the abbreviated market entry. Afidro stated this route would be risky for the health of Colombians, given it does not require clinical studies to fully guarantee safety, quality, and efficacy of the medications.

After a two year wait, the Council of State made its first pronouncement, through which it authorized the entry of the so-called biosimilars by means of the alleged abbreviated route. The decision is not yet final, but it will be understood as being effective while the case is under review and a final decision is made.