2nd MENA Stakeholder Meeting on Regulatory Approval, Clinical Settings, Interchangeability and Pharmacovigilance of Biosimilars 2018 – Report
Category: Meeting Report
341 total, 3 today
Keywords: costs, extrapolation, MENA (Middle East, North Africa), pharmacovigilance, regulators, switching
Introduction: The number of biosimilars, or similar biotherapeutic products, is expanding rapidly worldwide. A further 12 blockbuster biologicals are set to add to this number by 2020. Agreement about the best practices for the regulation, use, interchangeability and pharmacovigilance of biosimilars is lacking in many countries including in the Middle East and North Africa (MENA).
Methods: The second MENA stakeholder meeting on regulatory approval, clinical settings, interchangeability and pharmacovigilance of biosimilars was held in Dubai, UAE on 10 October 2018. The format and content were different to the first MENA stakeholder meeting held in Dubai in 2015, and included 10 speaker presentations, two panel discussions, five case study workgroup discussions, and one forum discussion. Participants included key opinion leader regulators, academics and medical practitioners/specialists, alongside pharmacologists, pharmacists and payers from MENA countries.
Results: There were clear areas of agreement among participants, but differences remain between different stakeholder groups – regulators, clinicians, pharmacologists and patients – and between MENA countries, Canada, Europe and the US.
Conclusion: Regulators must provide a full explanation of biosimilarity to pharmacists, clinicians and patients, while clinicians and patient groups must clearly explain to pharmacists and regulators the challenges they face in the clinic. Potential savings to health care will not be made without full collaboration by all stakeholders.
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