First MENA educational workshop on regulation and approval of similar biotherapeutic products/biosimilars, Dubai, United Arab Emirates, 1 September 2015

Abstract

Introduction: Similar biotherapeutic products (SBPs or biosimilars) include a rapidly expanding number of therapeutic products worldwide. However, agreement about the best practices for their regulation are lacking in many countries including in the Middle East and North Africa (MENA). Methods: The first MENA educational workshop on SBPs was held in Dubai, UAE on 1 September 2015. The format and content was similar to a previous workshop held in Mexico and included didactic presentations followed by interactive breakout sessions where the participants evaluated preclinical data that compared an innovator product to a fictional follow-on biological product, either a recombinant erythropoetin or an antitumour necrosis factor monoclonal antibody. Participants included clinicians, academic, physicians and pharmacists, as well as professionals with experience working in industry or regulatory bodies in both the European Union (EU) and MENA countries. Written and verbal summaries of the breakout sessions were presented and discussed in an attempt to identify any consensus about how decisions are or should be made about SBP approval. Results: Some areas of general consensus as well as many differences in approach, available resources, opinion and practice were identified concerning the regulatory evaluation of potential SBPs; both between different MENA countries and between the EU and MENA countries. Conclusion: There is a need to identify which approaches to the regulation, use and post-approval monitoring of SBPs can be most efficiently and effectively implemented in MENA countries in order to identify clinically important differences in biological product composition, efficacy, pricing and safety.