Productos Bioterapéuticos Similares (PBS). Panorama actual en América Latina en el contexto de la Artritis Reumatoide. Revisión sistemática de la literatura
Thesis
INTRODUCTION: Biotherapeutic products have changed the treatment of diseases like rheumatoid arthritis (RA). The high costs and the patent expiry of reference biotherapeutic products (innovators), have promoted the interest on similar biotherapeutic products (SBP), also known as biosimilars. METHODS: systemic review which have the objective of presenting the current scenario (to October 2012) of SBP in Latin America (LA) within the context of RA. Review of: international and latin-american databases, governmental websites, registry of clinical trials, news and relevant websites. The PRISMA guidelines were followed. RESULTS: Databases: selection of 30 articles according to inclusion criteria. Selection of 17 articles according to detailed review. Manual search: selection of 45 references. Total of 62 documents. Regulations on PBS: Mexico, Cuba, Guatemala, Costa Rica, Panamá, Venezuela, Peru, Brazil, Chile and Argentina. In Colombia there is a regulatory proposal that is in development. Approved SBP: Colombia (Etanar®, SBP of Etanercept), Mexico (Kikuzubam®, SBP of Rituximab), Peru, Chile and Bolivia (In these last 3 countries, Reditux®, PBS de Rituximab). DISCUSSION: the regulatory background on SBP in LA has been improved in the last 6 years, nevertheless regulations should seek to be clearer. Efforts should be developed to establish regulations in the Latin American countries that do not have them. Countries like Mexico, Cuba and Brazil have a growing biotechnology industry. Approval of SBP in LA has generated controversy and divided opinions among the various actors. Commercialization of SBP is beneficial, nevertheless clear regulations that ensure efficacy and safety must be followed for this purpose.
