LETTER TO THE EDITORS

Abstract

Biosimilars require scientifi cally reliable comparative clinical data © 2013 Elsevier Editora Ltda. All rights reserved. In Brazil, the Law 9787 of February 10, 1999, authorized the commercialization by any pharmaceutical company of drugs, whose patent protection expired, in a standardized packaging with a yellow band and a ‘G ’ of ‘generic’. Generic drugs are usually cheaper, because, after the expiration of the patent protection of their brand-name pharmaceutical products, manufacturers need neither to invest in clinical research, nor to redo the trials that confi rm the effi cacy and safety of a certain drug. Such costs are inherent to certain phases of the process of research and discovery of new pharmaceutical drugs, and have already been conducted by the innovator company that had fi rst obtained patent on a certain drug. Thus, manufactur-ers of generic drugs can sell their copies with the same quality of the brand-name pharmaceutical product at a lower price