Recommendations for the regulation of biosimilars and their implementation in Latin america

With the emergence of biosimilars as a new class of biotherapeutic agents, the use of these products in Latin America has become a focus of attention. To aid policymakers and regulatory authorities, a group of experts on biosimilars developed a series of recommendations for the regulation of biosimilars and their implementation in the region. Although most Latin American countries have adopted, in general, the WHO (World Health Organization) recommendations, there are some of them whose regulations differ from WHO. Unfortunately, the pace at which the region moves toward reaching its potential of having safe and effective biosimilars has been slow. Countries in the region must enhance their efforts to improve pharmacovigilance to include training more regulatory staff, more public and professional awareness on the importance of reporting adverse events and better systems to capture and analyze data. Regulatory authorities should also establish a process whereby the traceability of an adverse event to a biosimilar can be determined. Products previously approved as 'intended copy' drugs should be evaluated according to regulations specific to biosimilars. It cannot be assumed that a previously approved biopharmaceutical is actually a biosimilar, regardless of current clinical experience. Latin America is no exception to the slower-than-expected pace of developing regulations on biosimilars. The panel's perspectives on the current status led to six major recommendations in order to enhance the safe use of biosimilars in the region.