Biological Therapies in Immune-Mediated Inflammatory Diseases: Can Biosimilars Reduce Access Inequities?
Biological Therapies in Immune-Mediated Inflammatory Diseases: Can Biosimilars Reduce Access Inequities?
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DOI：
10.3389/fphar.2019.00279
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发表时间：
2019-03-28
影响因子：
5.6
通讯作者：
Taylor, Peter C.
中科院分区：
文献类型：
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作者：
Baumgart, Daniel C.;Misery, Laurent;Taylor, Peter C.
生物疗法是一系列免疫介导性炎症性疾病(IMID)的有效治疗方法，包括类风湿性关节炎、牛皮癣和炎症性肠道疾病。然而，由于其高昂的成本，世界各地，甚至在不同的欧洲国家，在使用它们方面存在着相当大的差异，许多国家尽管有专业协会的准则建议，但仍限制使用。在许多中欧和东欧国家，医疗保健提供者采用生物制品的情况尤其糟糕。在医疗专科、医疗保健提供者以及地区和国家一级也观察到了利用方面的差异。本文的目的是概述欧洲生物制品的不同市场准入政策，并调查造成这些差异的原因。在成本是主要障碍的情况下，为IMID患者提供更广泛的机会的潜在解决方案之一是鼓励使用生物仿制药来取代他们的参考产品。生物仿制药通常是已经获得许可的生物疗法的较便宜的替代品，批准的基础是它们在质量、安全性和有效性方面与参考产品相似。预算影响模型预测，在未来几年引入生物仿制药后，将节省大量成本。这些节省的资金可以用来增加获得生物制品和其他创新疗法的机会。
Biological therapies are an effective treatment for a range of immune-mediated inflammatory diseases (IMIDs), including rheumatoid arthritis, psoriasis, and inflammatory bowel diseases. However, due to their high costs, considerable differences in their utilization exist across the world, even among the various European countries, with many countries restricting access despite professional society guideline recommendations. Adoption of biologics by healthcare providers has been particularly poor in many Central and Eastern European countries. Differences in utilization have also been observed across medical specialties, healthcare providers, and at a regional and national level. The objective of this paper is to provide an overview of the different market access policies for biologics in Europe and to investigate reasons for such differences. One of the potential solutions for providing broader access to IMID patients, where cost is the major barrier, is to encourage the use of biosimilars in place of their reference products. Biosimilars are generally less expensive alternatives to already licensed biological therapies and are approved on the basis that they are similar to the reference product in terms of quality, safety, and efficacy. Budget impact models predict considerable cost savings following the introduction of biosimilars in the next few years. These savings could be used to increase access to biologics and other innovative therapies.