In Mid-October, the Brazilian regulatory authority ANVISA announced the establishment of an office for biological medicines. The purpose of the office is to provide advice and consulting on matters related to new biological products and biological products in general. The “Technical Office of Biological Products” will be made up of “renowned experts in the clinical and biotech areas,” according to the ANVISA press release.
Composed of seven regular members and up to three alternate members, appointed by the chief executive of the agency, participants will meet regularly every three months and, extraordinarily, in urgent cases. A primary goal of the group will be to evaluate biosimilars in an effort to bring more affordable biologics to the Brazilian population.