https://orcid.org/0000-0001-9878-7734
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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.
Supplementary Information
The online version contains supplementary material available at https://doi.org/10.1186/s40545-023-00581-w.
Supplementary Information
The online version contains supplementary material available at https://doi.org/10.1186/s40545-023-00581-w.
Acknowledgements
The authors wish to thank the survey respondents for their active participation and valuable inputs.
Author contributions
ZK, ANF, BE and ShA created the conceptual design. KAE, BE and ANF conducted the literature review and created the draft survey. ZK revised the survey and adjusted fine details.MG, AS, NH, NA, SA, NF, ASS, AE, AM, ASS, KE, ME, MT, NMM, RAA, RR and SA participated in the workshop, provided their opinions and responded to the survey. KAE, BE and ANF conducted the analysis and created the draft manuscript. All co-authors critically reviewed the manuscript and provided their feedback, then approved the final version of the manuscript. All authors agree to be accountable for all aspects of the work.
Funding
Open access funding provided by The Science, Technology & Innovation Funding Authority (STDF) in cooperation with The Egyptian Knowledge Bank (EKB). No funding was received for this study.
Availability of data and materials
All data generated or analyzed during this study are included in this published article and its supplementary information files.
Declarations
Ethics approval and consent to participate
Not applicable.
Consent for publication
Since there are no individual details in our result, consent for publication is not applicable.
Competing interests
The authors report no conflicts of interest.
Supplementary Information
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