Understanding the political framework of biopharmaceutical development in Brazil: the case of monoclonal antibodies

Over the last three decades, some industrialized countries have implemented a set of scientific, technological, and industrial policies to improve the economic landscape of the new emerging biopharmaceutical industry. Biopharmaceuticals generally refers to medicines developed using biotechnological methods (such as the culture of cells from mice and other mammals, cultivated under rigorous quality controls and best practices), as well as drugs produced using DNA technologies and genomic and proteomic techniques (Ecker et al., 2015). This article aims to provide an introductory analysis of the political framework under implementation for the development and manufacturing of the so-called Monoclonal Antibodies (mAbs) in Brazil. We conducted a documental research on articles available in the Web of Science and reports and website information of federal governmental agencies. We also applied 28 interviews with the main stakeholders involved in the Brazilian mAbs biopharmaceutical development agenda.