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.

Reviewing non clinical data for a granulocyte colony stimulatory factor product: experience in Brazil.

Non clinical studies are one of the requirements for the Brazilian National Regulatory Authority, ANVISA, for licensing a similar biotherapeutic product. During the WHO/KFDA workshop on implementing WHO guidelines on evaluating similar biotherapeutic products (SBP) in Seoul, Republic of Korea, the Brazilian experience with the non clinical studies of a Granulocyte Colony Stimulatory Factor (G-CSF), filgrastim, was presented. The applicant presented a reduced non clinical data package, but the key studies with relevant species were conducted and the non-clinical studies were considered sufficient for approval.

Lactobacillus delbrueckii as a potential skin adjuvant for induction of type 1 immune responses.

We evaluated the ability of Lactobacillus delbrueckii UFV H2b20, a probiotic candidate, to stimulate the production of inflammatory cytokines and to induce macrophage activation and Th1 differentiation in peripheral blood mononuclear cells (PBMC) from healthy volunteers. Our results show that PBMC stimulated with heat-killed Lact. delbrueckii produced elevated levels of IL-12, IFN-gamma and TNF-alpha but no IL-10.