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Maximizing the benefits of using biosimilars in Egypt

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...

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Autores principales: Fasseeh, Ahmad Nader, Elezbawy, Baher, El-Fass, Kareem Ahmed, GamaI, Mary, Seyam, Ahmed, Hayek, Noha, Abdel Rahman, Nagwan, Abdelhamid, Sohir, Fasseeh, Nader, Saad, Amr Shafik, Elagamy, Ahmed, Mahmoud, Akram, Sedrak, Amal Samir, Elshazly, Khaled, Eldebeiky, Mariam, Talaat, Monica, Mohamed, Noura Maher, Abdelaziz, Rania Ahmed, Refaat, Remonda, Akeel, Shaimaa, Abaza, Sherif, Kaló, Zoltán
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10291771/
https://www.ncbi.nlm.nih.gov/pubmed/37365620
http://dx.doi.org/10.1186/s40545-023-00581-w
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author Fasseeh, Ahmad Nader
Elezbawy, Baher
El-Fass, Kareem Ahmed
GamaI, Mary
Seyam, Ahmed
Hayek, Noha
Abdel Rahman, Nagwan
Abdelhamid, Sohir
Fasseeh, Nader
Saad, Amr Shafik
Elagamy, Ahmed
Mahmoud, Akram
Sedrak, Amal Samir
Elshazly, Khaled
Eldebeiky, Mariam
Talaat, Monica
Mohamed, Noura Maher
Abdelaziz, Rania Ahmed
Refaat, Remonda
Akeel, Shaimaa
Abaza, Sherif
Kaló, Zoltán
author_facet Fasseeh, Ahmad Nader
Elezbawy, Baher
El-Fass, Kareem Ahmed
GamaI, Mary
Seyam, Ahmed
Hayek, Noha
Abdel Rahman, Nagwan
Abdelhamid, Sohir
Fasseeh, Nader
Saad, Amr Shafik
Elagamy, Ahmed
Mahmoud, Akram
Sedrak, Amal Samir
Elshazly, Khaled
Eldebeiky, Mariam
Talaat, Monica
Mohamed, Noura Maher
Abdelaziz, Rania Ahmed
Refaat, Remonda
Akeel, Shaimaa
Abaza, Sherif
Kaló, Zoltán
author_sort Fasseeh, Ahmad Nader
collection PubMed
description 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 10.1186/s40545-023-00581-w.
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spelling pubmed-102917712023-06-27 Maximizing the benefits of using biosimilars in Egypt Fasseeh, Ahmad Nader Elezbawy, Baher El-Fass, Kareem Ahmed GamaI, Mary Seyam, Ahmed Hayek, Noha Abdel Rahman, Nagwan Abdelhamid, Sohir Fasseeh, Nader Saad, Amr Shafik Elagamy, Ahmed Mahmoud, Akram Sedrak, Amal Samir Elshazly, Khaled Eldebeiky, Mariam Talaat, Monica Mohamed, Noura Maher Abdelaziz, Rania Ahmed Refaat, Remonda Akeel, Shaimaa Abaza, Sherif Kaló, Zoltán J Pharm Policy Pract Research 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 10.1186/s40545-023-00581-w. BioMed Central 2023-06-26 /pmc/articles/PMC10291771/ /pubmed/37365620 http://dx.doi.org/10.1186/s40545-023-00581-w Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Research
Fasseeh, Ahmad Nader
Elezbawy, Baher
El-Fass, Kareem Ahmed
GamaI, Mary
Seyam, Ahmed
Hayek, Noha
Abdel Rahman, Nagwan
Abdelhamid, Sohir
Fasseeh, Nader
Saad, Amr Shafik
Elagamy, Ahmed
Mahmoud, Akram
Sedrak, Amal Samir
Elshazly, Khaled
Eldebeiky, Mariam
Talaat, Monica
Mohamed, Noura Maher
Abdelaziz, Rania Ahmed
Refaat, Remonda
Akeel, Shaimaa
Abaza, Sherif
Kaló, Zoltán
Maximizing the benefits of using biosimilars in Egypt
title Maximizing the benefits of using biosimilars in Egypt
title_full Maximizing the benefits of using biosimilars in Egypt
title_fullStr Maximizing the benefits of using biosimilars in Egypt
title_full_unstemmed Maximizing the benefits of using biosimilars in Egypt
title_short Maximizing the benefits of using biosimilars in Egypt
title_sort maximizing the benefits of using biosimilars in egypt
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10291771/
https://www.ncbi.nlm.nih.gov/pubmed/37365620
http://dx.doi.org/10.1186/s40545-023-00581-w
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