生物仿制药在拉丁美洲医疗保健可持续性方面的潜在作用。

IF 3.6 3区 医学 Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY
Rony Schaffel, Paul Cornes, Manuel A Espinoza, David Gómez-Almaguer, Angelo Maiolino, Daniel Freire, Tobias Foierl
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引用次数: 0

摘要

拉丁美洲(LatAm)国家面临着医疗保健支出的显著增加,这主要是由于人口增长和老龄化,以及癌症和其他慢性病患病率的上升。不断增长的需求和高昂的成本对该地区患者获得生物药物构成了障碍。生物仿制药可以提高生物制剂的可负担性和可及性,支持医疗保健的长期可持续性。然而,它们在拉丁美洲的普及速度普遍较慢。涵盖的领域:生物类似药使用的挑战和障碍,以及利用欧洲和美国的经验,增加拉丁美洲生物类似药使用的潜在战略。专家意见:推动拉丁美洲生物类似药使用的潜在举措包括:(1)协调生物类似药的监管流程,制定优先使用生物类似药的报销政策和鼓励处方的激励措施;(2)对主要利益相关者进行教育,以限制对生物仿制药的错误信息,保证安全性和有效性,并增加理解和接受度;(3)简化了生物仿制药的卫生技术评估流程,加快或调整了传统方法的某些方面;(4)协调区域努力,使国家卫生保健系统能够以最具成本效益的方式采购药品,并利用价值框架支持决策和集中采购、竞争政策和风险分担协议的实施。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
The potential role of biosimilars in healthcare sustainability in Latin America.

Introduction: Latin American (LatAm) countries face significant increases in healthcare expenditure, driven largely by population growth and aging, and the rising prevalence of cancer and other chronic diseases. Growing demand and high costs of biologic medicines present barriers to patient access in this region. Biosimilars can improve the affordability and accessibility of biologics, supporting long-term healthcare sustainability. However, their uptake in LatAm has generally been slow.

Areas covered: Challenges and barriers to the use of biosimilars and potential strategies to increase biosimilar uptake in LatAm, drawing on learnings from Europe and the U.S.A.

Expert opinion: Potential initiatives to drive biosimilar uptake across LatAm include (1) harmonized regulatory processes for biosimilars, with reimbursement policies that prioritize their use and incentives to encourage prescribing; (2) education for key stakeholders to limit misinformation about biosimilars, provide reassurance about safety and efficacy, and increase understanding and acceptance; (3) simplified health technology assessment processes for biosimilars that expedite or adapt some aspects of the traditional approach; and (4) coordinated regional efforts to enable national healthcare systems to purchase medicines in the most cost-effective way, with value frameworks to support decision-making and the implementation of centralized purchasing, competition policies, and risk-sharing agreements.

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来源期刊
Expert Opinion on Biological Therapy
Expert Opinion on Biological Therapy 医学-生物工程与应用微生物
CiteScore
8.60
自引率
0.00%
发文量
96
审稿时长
3-8 weeks
期刊介绍: Expert Opinion on Biological Therapy (1471-2598; 1744-7682) is a MEDLINE-indexed, international journal publishing peer-reviewed research across all aspects of biological therapy. Each article is structured to incorporate the author’s own expert opinion on the impact of the topic on research and clinical practice and the scope for future development. The audience consists of scientists and managers in the healthcare and biopharmaceutical industries and others closely involved in the development and application of biological therapies for the treatment of human disease. The journal welcomes: Reviews covering therapeutic antibodies and vaccines, peptides and proteins, gene therapies and gene transfer technologies, cell-based therapies and regenerative medicine Drug evaluations reviewing the clinical data on a particular biological agent Original research papers reporting the results of clinical investigations on biological agents and biotherapeutic-based studies with a strong link to clinical practice Comprehensive coverage in each review is complemented by the unique Expert Collection format and includes the following sections: Expert Opinion – a personal view of the data presented in the article, a discussion on the developments that are likely to be important in the future, and the avenues of research likely to become exciting as further studies yield more detailed results; Article Highlights – an executive summary of the author’s most critical points.
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