Khalid A Alnaqbi, Ahmed Al-Jedai, Mohamed Farghaly, Mohammed A Omair, Anas Hamad, Fatemah M A Abutiban, Ali Al Shirawi, Hanan Al Rayes, Sarah Aldallal, Sahar Fahmy, Steven Simoens
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The discussion was structured around a conceptual biosimilar value framework and an overview of biosimilar policies as derived from a targeted review of the peer-reviewed and grey literature.</p><p><strong>Results: </strong>The expert panel agreed on a biosimilar value framework for the GCC countries that is founded on trust, cost savings and contextual considerations. They emphasized the importance of launching educational initiatives that build trust in and expand knowledge of all stakeholders about biosimilars. This also includes making stakeholders aware of the various value propositions of biosimilars as an instrument to produce, for example, cost savings. Finally, they stressed that biosimilar adoption is influenced by contextual factors such as incentives and implementation efforts.</p><p><strong>Conclusion: </strong>Our proposed biosimilars value framekwork is the first set of recommendations in the Arab countries designed to help policymakers and decision-makers promote biosimilar adoption, both in high-income GCC countries and in low- and middle-income countries.</p>","PeriodicalId":23084,"journal":{"name":"Therapeutic innovation & regulatory science","volume":null,"pages":null},"PeriodicalIF":2.0000,"publicationDate":"2024-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Expert Consensus Recommendations on a Biosimilars Value Framework for the Gulf Cooperation Council Countries.\",\"authors\":\"Khalid A Alnaqbi, Ahmed Al-Jedai, Mohamed Farghaly, Mohammed A Omair, Anas Hamad, Fatemah M A Abutiban, Ali Al Shirawi, Hanan Al Rayes, Sarah Aldallal, Sahar Fahmy, Steven Simoens\",\"doi\":\"10.1007/s43441-024-00716-4\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>This paper aims to develop a biosimilar value framework with local stakeholders in Gulf Cooperation Council (GCC) countries.</p><p><strong>Methods: </strong>A convenience sample of ten key opinion leaders from the United Arab Emirates, Kingdom of Saudi Arabia, Kuwait, Oman and Qatar participated in an expert panel meeting in November 2022 that examined factors positively influencing biosimilar adoption in these countries. The discussion was structured around a conceptual biosimilar value framework and an overview of biosimilar policies as derived from a targeted review of the peer-reviewed and grey literature.</p><p><strong>Results: </strong>The expert panel agreed on a biosimilar value framework for the GCC countries that is founded on trust, cost savings and contextual considerations. They emphasized the importance of launching educational initiatives that build trust in and expand knowledge of all stakeholders about biosimilars. This also includes making stakeholders aware of the various value propositions of biosimilars as an instrument to produce, for example, cost savings. Finally, they stressed that biosimilar adoption is influenced by contextual factors such as incentives and implementation efforts.</p><p><strong>Conclusion: </strong>Our proposed biosimilars value framekwork is the first set of recommendations in the Arab countries designed to help policymakers and decision-makers promote biosimilar adoption, both in high-income GCC countries and in low- and middle-income countries.</p>\",\"PeriodicalId\":23084,\"journal\":{\"name\":\"Therapeutic innovation & regulatory science\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":2.0000,\"publicationDate\":\"2024-10-30\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Therapeutic innovation & regulatory science\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1007/s43441-024-00716-4\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"MEDICAL INFORMATICS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Therapeutic innovation & regulatory science","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s43441-024-00716-4","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"MEDICAL INFORMATICS","Score":null,"Total":0}
Expert Consensus Recommendations on a Biosimilars Value Framework for the Gulf Cooperation Council Countries.
Objective: This paper aims to develop a biosimilar value framework with local stakeholders in Gulf Cooperation Council (GCC) countries.
Methods: A convenience sample of ten key opinion leaders from the United Arab Emirates, Kingdom of Saudi Arabia, Kuwait, Oman and Qatar participated in an expert panel meeting in November 2022 that examined factors positively influencing biosimilar adoption in these countries. The discussion was structured around a conceptual biosimilar value framework and an overview of biosimilar policies as derived from a targeted review of the peer-reviewed and grey literature.
Results: The expert panel agreed on a biosimilar value framework for the GCC countries that is founded on trust, cost savings and contextual considerations. They emphasized the importance of launching educational initiatives that build trust in and expand knowledge of all stakeholders about biosimilars. This also includes making stakeholders aware of the various value propositions of biosimilars as an instrument to produce, for example, cost savings. Finally, they stressed that biosimilar adoption is influenced by contextual factors such as incentives and implementation efforts.
Conclusion: Our proposed biosimilars value framekwork is the first set of recommendations in the Arab countries designed to help policymakers and decision-makers promote biosimilar adoption, both in high-income GCC countries and in low- and middle-income countries.
期刊介绍:
Therapeutic Innovation & Regulatory Science (TIRS) is the official scientific journal of DIA that strives to advance medical product discovery, development, regulation, and use through the publication of peer-reviewed original and review articles, commentaries, and letters to the editor across the spectrum of converting biomedical science into practical solutions to advance human health.
The focus areas of the journal are as follows:
Biostatistics
Clinical Trials
Product Development and Innovation
Global Perspectives
Policy
Regulatory Science
Product Safety
Special Populations