关于海湾合作委员会国家生物仿制药价值框架的专家共识建议。

IF 2 4区 医学 Q4 MEDICAL INFORMATICS Therapeutic innovation & regulatory science Pub Date : 2024-10-30 DOI:10.1007/s43441-024-00716-4
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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引用次数: 0

摘要

目的本文旨在与海湾合作委员会(GCC)国家的当地利益相关者共同制定生物仿制药价值框架:2022 年 11 月,来自阿拉伯联合酋长国、沙特阿拉伯王国、科威特、阿曼和卡塔尔的 10 位关键意见领袖参加了一次专家小组会议,会议探讨了对这些国家采用生物仿制药产生积极影响的因素。讨论围绕生物仿制药价值概念框架和生物仿制药政策概述展开,该框架和概述来自对同行评审和灰色文献的针对性审查:专家小组就海湾合作委员会国家的生物仿制药价值框架达成了一致意见,该框架建立在信任、成本节约和环境因素的基础上。他们强调了开展教育活动的重要性,以建立所有利益相关者对生物仿制药的信任并扩大他们对生物仿制药的了解。这还包括让利益相关方了解生物仿制药的各种价值主张,例如作为节约成本的工具。最后,他们强调,生物仿制药的采用受到激励措施和实施力度等环境因素的影响:我们提出的生物仿制药价值框架是阿拉伯国家的第一套建议,旨在帮助政策制定者和决策者促进生物仿制药的采用,无论是在高收入的海湾合作委员会国家,还是在中低收入国家。
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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.

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来源期刊
Therapeutic innovation & regulatory science
Therapeutic innovation & regulatory science MEDICAL INFORMATICS-PHARMACOLOGY & PHARMACY
CiteScore
3.40
自引率
13.30%
发文量
127
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
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