Current development in regulation of similar biotherapeutic products in Brazil.

Because of the recent expiry of a large number of patents on the originator biological products, interest in the production and marketing of similar biotherapeutic products in Brazil has been increasing. The national producers have significant interest in this market and have been making a large amount of investments in these kinds of products. Since biotherapeutic products consume a large amount of the government health budget, the Brazilian government also has a big interest in the possibility that more affordable biotherapeutic products could be introduced into the market to improve access, but always is concerned with the quality, safety and efficacy of these products Accordingly, it was necessary to review the biological product regulations in Brazil and to establish specific pathways to license similar biotherapeutic products. The new Brazilian regulations, Resolution no. 55/2010, are based on different regulations and guidelines from around the world, including the WHO SBP Guidelines. They follow the same scientific principles as the WHO Guidelines but also have some differences which are due to specific country needs.