Centro de Investigación y de Estudios Avanzados del Instituto Politécnico Nacional Av. Instituto Politécnico Nacional 2508, Colonia San Pedro Zacatenco, Mexico City, Mexico.
Department of Pharmacology, Centro de Investigación y de Estudios Avanzados del Instituto Politécnico Nacional, Av. Instituto Politécnico Nacional 2508, 07360, Mexico City, Mexico.
Adv Ther. 2024 Dec;41(12):4357-4368. doi: 10.1007/s12325-024-02990-y. Epub 2024 Oct 9.
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.
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.
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.
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.
生物类似药为改善拉丁美洲获得生物治疗的机会带来了显著优势。然而，由于存在误解、监管不确定性以及药物警戒不足，其采用速度较为缓慢。
为了解决这些问题，美洲健康基金会召集了来自拉丁美洲的生物类似药使用和可互换性方面的多学科区域专家小组。该小组评估了当前的情况，并提出了加强可及性的建议措施。
关键建议包括加强生物类似药监管，确保透明执行，实施强有力的药物警戒，并促进利益相关者之间的合作，以教育患者了解生物类似药及其可互换性的安全性、有效性和经济性优势。
通过采用生物类似药和可互换性，拉丁美洲国家可以扩大患者的可及性，促进竞争，使治疗来源多样化，并提高其医疗保健系统的可持续性。然而，要实现这些目标，需要解决医疗保健提供者、患者、监管机构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。
