First Latin American educational workshop on similar biotherapeutic products, Mexico City, Mexico, 20 January 2015

Abstract

Introduction: Similar Biotherapeutic Products (SBPs or biosimilars) comprise a rapidly expanding area of therapeutics worldwide. However, best practices for their regulation are lacking in many Latin American countries. Methods: The first in a series of educational workshops on SBPs in Latin America was held in Mexico City on 20 January 2015. Didactic presentations covered the preclinical development, production, analysis, use and post-marketing surveillance of SBPs. Practicing clinicians, academics, drug regulators, and industry representatives participated in interactive sessions that evaluated preclinical data comparisons with an innovator product for two fictional follow-on biological products, one a recombinant native protein and the other a monoclonal antibody, and gave their opinions as to whether/what additional further testing was needed for approval. Results: Discussions identified knowledge gaps as well as many differences of opinion and practice concerning the regulatory evaluation of potential SBPs. Conclusion: There is a need to identify improved, best practices for the regulation, use and post-approval monitoring of SBPs in Mexico and other Latin American countries in order to identify important differences in product composition, efficacy and safety.