Recommendations for Interchangeability in a Growing Biosimilar Market in Latin America

IF 3.4 3区医学 Q2 MEDICINE, RESEARCH & EXPERIMENTAL

Advances in Therapy Pub Date : 2024-10-09 DOI:10.1007/s12325-024-02990-y

Gilberto Castañeda-Hernández, Manuel Antonio Espinoza, Luis Eduardo Pino, Mariana Rico-Restrepo, Bianca Schiavetti, Enrique Terán, Valderilio Feijo Azevedo

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引用次数: 0

Abstract

Background

Biosimilars offer significant advantages for improving access to biologic treatments in Latin America. However, their uptake has been slow due to misconceptions, regulatory uncertainties, and inadequate pharmacovigilance.

Objective

To address these issues, Americas Health Foundation convened a multidisciplinary panel of regional experts in biosimilar use and interchangeability from Latin America. The panel assessed the current landscape and recommended steps to enhance access.

Results

Key recommendations include strengthening biosimilar regulations, ensuring transparent enforcement, implementing robust pharmacovigilance, and promoting collaboration among stakeholders to educate about the safety, efficacy, and economic advantages of biosimilars and their interchangeability.

Conclusions

By embracing biosimilars and interchangeability, Latin American countries can expand patient access, foster competition, diversify treatment sources, and enhance the sustainability of their healthcare systems. However, achieving these goals requires addressing knowledge gaps and biases among healthcare providers, patients, regulators, and government agencies. This can be accomplished through clear communication and the use of real-world evidence.

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关于在拉丁美洲不断增长的生物仿制药市场中实现互换性的建议。

背景：生物仿制药在改善拉丁美洲生物治疗的可及性方面具有显著优势。然而，由于误解、监管不确定性和药物警戒不足等原因，生物仿制药的使用一直进展缓慢：为了解决这些问题，美洲健康基金会召集了一个由拉丁美洲生物仿制药使用和互换性方面的地区专家组成的多学科小组。该小组评估了目前的状况，并提出了提高可及性的建议：主要建议包括加强生物仿制药法规、确保透明执法、实施强有力的药物警戒、促进利益相关者之间的合作，以宣传生物仿制药的安全性、有效性和经济优势及其互换性：通过接受生物仿制药和互换性，拉美国家可以扩大患者就医途径，促进竞争，使治疗来源多样化，并增强其医疗保健系统的可持续性。然而，实现这些目标需要解决医疗服务提供者、患者、监管者和政府机构之间的知识差距和偏见。这可以通过清晰的沟通和使用真实世界的证据来实现。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Advances in Therapy 医学-药学

CiteScore

7.20

自引率

2.60%

发文量

353

审稿时长

6-12 weeks

期刊介绍： Advances in Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all therapeutic areas. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged. The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Advances in Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.