There have been many changes in Mexico's biocomparable market in Mexico. In their article "Moving Forward: biologics and biocomparables in Mexico" Daniel Sanchez and Vicotr Ramirez discuss this trend.
Although some provisions have been enacted, there are many things left to do and many of these are currently under discussion in industry and government. In fact, there is a bill pending with the Mexican Congress to include a new provision, Article 222 bis of the LGS. That bill is focused on solving problems related to the non-interchangeability of biological drugs in the health sector thereby improving pharmacovigilance programmes for medications. The bill is designed to meet the constitutional objectives related to the public purchase of goods on the best terms of pricing and quality for the public health system.
Another bill currently under discussion in the Health Commission of the Mexican Congress seeks to have electronic control of all medicines in Mexico, including a two-dimensional code and some colour-labelling provisions for different medicines. This bill also treats the sale of expired medicines as a felony.
What is the impact of these legislations to the market? What does industry think about this?