New rules for marketing approval of biosimilar medicines in Brazil


Otto Licks and Patricia Helena Nunes

On December 17, 2010, Anvisa issued Regulation No. 55/2010, establishing the requirements for granting marketing approval to new biological products and biological products.

Despite the fact that the Brazilian legislation does not use the terms ‘biosimilars’ or ‘biogenerics’, the concept of registration by reference to third parties’ data packages is fully supported by the regulation. This raises concerns regarding Brazil’s widespread lack of enforcement of data package exclusivity (DPE).

A request for marketing approval of biological products (not new) can be made in two different ways: individual development and development by comparability. When choosing individual development, the applicant must submit a technical report, non-clinical studies and clinical studies performed on the product. However, the scope of the non-clinical studies can be reduced and the phase I and II studies can be exempted.

Phase III studies are mandatory (with exceptions) and must be comparatives of ‘non-inferiority’, ‘equivalence’ or ‘superiority’ to the new biological product. Otherwise, when using the development by comparability standard, it is necessary to submit a comparative dossier containing non-clinical and clinical studies used to demonstrate comparability between the biological product to be approved and the biological product used as a comparator.

Brazil, biosimilar medicines