Stojanova Jana, Lutz Mariane, Lazcano Gabriel, Arancibia Marcelo
Centro Interdisciplinario de Estudios en Salud (CIESAL), Escuela de Medicina, Universidad de Valparaíso, Viña del Mar, Chile. ORCID: 0000-0003-4812-5745.
Centro Interdisciplinario de Estudios en Salud (CIESAL), Escuela de Medicina, Universidad de Valparaíso, Viña del Mar, Chile. ORCID: 0000-0001-6665-6748.
Medwave. 2020 Feb 25;20(2):e7825. doi: 10.5867/medwave.2020.01.7825.
Medicines are an economic good and a fundamental component of public and private spending and health decision-making. Assurance of their quality, efficiency and safety is essential. However, the variety of products on the Chilean market, including innovative and generic productsthe latter accounted for by many products that are certified as bioequivalent while others are notresults in a potentially confusing scenario for consumers and health providers. In this review, we intend to shed light on the concepts of bioequivalency (applicable to compounds of small molecular size) and biosimilarity (applicable to biological compounds of greater molecular complexity). In both cases, how the active substance interacts with the host organism must be demonstrated by studies carried out for this purpose. A direct application of the concept of bioequivalence is interchangeability, defined as the possibility of using a product of the same active principle, as long as the pharmaceutical form and dosage scheme are the same. Regulations related to bioequivalence and biosimilarity must not only guarantee safety and efficacy when products are interchanged, but also facilitate cost savings and access to medicines. Likewise, the implementation of evidence-based guidelines that standardize concepts of interchangeability should be encouraged, as this could lead to a more educated usage and a reduction in the information asymmetry between patients (users) and the industry. The importance of interchangeability of medicines is particularly relevant in two governmental health initiatives in Chile: the Explicit Health Guarantees Plan (GES) and the Financial Protection for Diagnoses and Treatments of High Cost, known as the Ricarte Soto Act. Nonetheless, it is not possible to guarantee that all alternative products to an innovative drug on the Chilean market are bioequivalent. The synthesis of knowledge available on this subject may impact and contribute to decision-making by stakeholders. It could also help to develop better health policies regarding bioequivalent and biosimilar pharmaceutical products in our country.
药品是一种经济商品，是公共和私人支出以及医疗决策的基本组成部分。确保其质量、有效性和安全性至关重要。然而，智利市场上的产品种类繁多，包括创新产品和仿制药——后者中有许多产品被认证为生物等效，而其他一些则没有——这给消费者和医疗服务提供者带来了潜在的困惑。在本综述中，我们旨在阐明生物等效性（适用于小分子化合物）和生物相似性（适用于分子复杂性更高的生物化合物）的概念。在这两种情况下，都必须通过为此目的进行的研究来证明活性物质与宿主生物体的相互作用方式。生物等效性概念的直接应用是可互换性，定义为只要药物剂型和给药方案相同，就可以使用具有相同活性成分的产品。与生物等效性和生物相似性相关的法规不仅必须在产品互换时保证安全性和有效性，还应促进成本节约和药品可及性。同样，应鼓励实施基于证据的指南，以规范可互换性的概念，因为这可能会带来更明智的用药方式，并减少患者（使用者）与行业之间的信息不对称。药品可互换性的重要性在智利的两项政府医疗举措中尤为突出：明确健康保障计划（GES）和高成本诊断与治疗的财务保护，即《里卡特·索托法案》。尽管如此，无法保证智利市场上创新药物的所有替代产品都是生物等效的。关于这一主题的现有知识综合可能会影响利益相关者的决策并为之做出贡献。它还可能有助于制定我国关于生物等效和生物相似药品的更好的卫生政策。
