Alnaqbi Khalid A, Al-Jedai Ahmed, Farghaly Mohamed, Omair Mohammed A, Hamad Anas, Abutiban Fatemah M A, Shirawi Ali Al, Rayes Hanan Al, Aldallal Sarah, Fahmy Sahar, Simoens Steven
Rheumatology Division, Sheikh Tahnoon Medical City and Tawam Hospital, Al Ain, UAE.
Internal Medicine Department, College of Medicine and Health Sciences, UAE University, Al Ain, UAE.
Ther Innov Regul Sci. 2025 Jan;59(1):153-163. doi: 10.1007/s43441-024-00716-4. Epub 2024 Oct 30.
This paper aims to develop a biosimilar value framework with local stakeholders in Gulf Cooperation Council (GCC) countries.
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.
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.
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.
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一个生物类似药价值框架。
从阿拉伯联合酋长国、沙特阿拉伯王国、科威特、阿曼和卡塔尔选取了十位关键意见领袖作为便利样本，他们参加了2022年11月的一次专家小组会议，该会议探讨了对这些国家生物类似药采用有积极影响的因素。讨论围绕一个概念性的生物类似药价值框架以及从同行评审文献和灰色文献的定向综述中得出的生物类似药政策概述展开。
专家小组就适用于海湾合作委员会国家的生物类似药价值框架达成一致，该框架基于信任、成本节约和背景因素。他们强调开展教育倡议的重要性，这些倡议要建立所有利益相关者对生物类似药的信任并扩大他们对生物类似药的了解。这还包括让利益相关者意识到生物类似药的各种价值主张，比如作为一种实现成本节约的手段。最后，他们强调生物类似药的采用受激励措施和实施力度等背景因素的影响。
我们提出的生物类似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类似药在高收入的海湾合作委员会国家以及低收入和中等收入国家的采用。
