Abstract
Introduction: A meeting was organized by the Generics and Biosimilars Initiative (GaBI) in collaboration with Saudi Pharmaceutical Society (SPS), to discuss the regulation, approval process, interchangeability/substitution, and post-marketing surveillance of biosimilars in Gulf Cooperation Council (GCC) countries. This 'First GCC Stakeholder Meeting on Approval Process, Interchangeability/Substitution and Safety of Biosimilars', took place on 20 November 2017, in Riyadh, Saudi Arabia and gave relevant stakeholders an opportunity to discuss these concepts between themselves and with experts from Saudi Arabia and abroad.
Methods: The meeting brought regulators from GCC countries and academics, medical specialists, and pharmacologists and pharmacists from Saudi Arabia together with experts from Italy, Norway, Saudi Arabia and the US, to share knowledge and exchange information. There were a number of expert speaker presentations with an interactive panel discussion. Following this, the audience was presented with data for two semi-fictional similar biotherapeutic products. The participants were divided into two discussion groups where they evaluated the fictional data supplied.
Results: The presentations were successful in conveying information about the current state of biosimilar regulation, approval, interchangeability/substitution, and post-marketing surveillance of effectiveness and safety. This resulted in a useful interactive discussion from which clearly defined action points could be extracted.
Conclusion: Biosimilar medicines are becoming increasingly available and used across GCC countries. The First GCC biosimilars stakeholder meeting was successful in bringing representatives from GCC nations together with those from Europe and the US, to discuss the best routes forward for successful biosimilar approval and regulation and enabled action points to facilitate biosimilar uptake with appropriate pharmacovigilance to be outlined.