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ABSTRACT: Background
Biosimilars constitute a pathway for sustainable financing of healthcare systems in the era of expensive biologics. However, such a pathway is not free of challenges. Since the biosimilars market is expanding in Egypt, there is an urgent need for a policy framework to optimize their use and diffusion in the market. We aim to characterize a national framework based on the experiences of other countries and consultation with local experts.Methods
A narrative literature review was conducted to identify biosimilars' policy elements worldwide. A workshop was organized with experts to discuss the narrative review findings and create consensus on recommendations.Results
The narrative literature review highlighted the need for biosimilar policy actions in four areas: market authorization, pricing, reimbursement, and uptake. Eighteen experts representing the Egyptian healthcare authorities attended the workshop. The most significant conclusions from the workshop included setting the price of the biosimilar at 30-40% less than its originator's price and establishing financing protocols, in which the more expensive biologics with significant price premiums should be excluded from the formulary.Conclusions
A summarized national framework policy recommendation for biosimilars was created by local experts from the main public healthcare entities in Egypt. These recommendations coincide with the international policies adopted across different countries that aim to improve patient access while sustaining health expenditure.
SUBMITTER: Fasseeh AN
PROVIDER: S-EPMC10291771 | biostudies-literature | 2023 Jun
REPOSITORIES: biostudies-literature
Fasseeh Ahmad Nader AN Elezbawy Baher B El-Fass Kareem Ahmed KA GamaI Mary M Seyam Ahmed A Hayek Noha N Abdel Rahman Nagwan N Abdelhamid Sohir S Fasseeh Nader N Saad Amr Shafik AS Elagamy Ahmed A Mahmoud Akram A Sedrak Amal Samir AS Elshazly Khaled K Eldebeiky Mariam M Talaat Monica M Mohamed Noura Maher NM Abdelaziz Rania Ahmed RA Refaat Remonda R Akeel Shaimaa S Abaza Sherif S Kaló Zoltán Z
Journal of pharmaceutical policy and practice 20230626 1
<h4>Background</h4>Biosimilars constitute a pathway for sustainable financing of healthcare systems in the era of expensive biologics. However, such a pathway is not free of challenges. Since the biosimilars market is expanding in Egypt, there is an urgent need for a policy framework to optimize their use and diffusion in the market. We aim to characterize a national framework based on the experiences of other countries and consultation with local experts.<h4>Methods</h4>A narrative literature r ...[more]