LAUSR

Biologic therapy is one of the great medical achievements of the last decades. More than 250 of the commercially available products and more than half of the oncologic therapies in development are biologic, and some monoclonal antibodies (mAbs) are included in the WHO Essential Medicines List. Despite the cost of these drugs, 350 million people worldwide are estimated to use biologic therapies regularly. In Brazil, many of the evidence-supported indications of mAbs in oncology (eg, trastuzumab in metastatic breast cancer) are not provided by the public health system. Nevertheless, the Brazilian Health Regulatory Agency (ANVISA) already has an advanced framework to analyze biosimilar approvals via two possible pathways: the comparative way, in which strong preclinical and immunogenicity data are scrutinized, and indispensable phase III clinical trials are assessed on a case-by-case basis, and the individual development pathway, in which quality issue and clinical study requirements are lower, but extrapolations are not allowed. In 2014, 12% of the medicines bought by the Brazilian Health Ministry were biologic, and this acquisition corresponded to 61% of the budget for chronic disease drugs. In fact, many of these biopharmaceuticals were biosimilars produced in public laboratories by product development partnerships that encourage technology transfer from private companies.