Division of Kidney Diseases and Hypertension, Department of Medicine, North Shore University Hospital and Long Island Jewish Medical Center, Hofstra North Shore-Long Island Jewish School of Medicine, Great Neck, NY.
Division of Kidney Diseases and Hypertension, Department of Medicine, North Shore University Hospital and Long Island Jewish Medical Center, Hofstra North Shore-Long Island Jewish School of Medicine, Great Neck, NY.
Am J Kidney Dis. 2015 Apr;65(4):537-42. doi: 10.1053/j.ajkd.2014.11.018. Epub 2015 Jan 10.
Biologic drugs, including epoetin, continue to play an important role in the management of medical conditions. However, biologics are costly and soon many of the patents on these drugs will expire, making way for non-brand name products (ie, biosimilars). It is only by introducing competition to the marketplace that costs will de-escalate. In Europe, a specific regulatory pathway for approving biosimilars has been in place since 2005. A similar review pathway in the United States has been developed by the US Food and Drug Administration. These guidelines for approving biosimilars are stringent, requiring preclinical pharmacodynamic and toxicologic studies, clinical studies to demonstrate bioequivalence and efficacy, and long-term postmarketing studies to monitor drug safety. Biosimilar epoetin has been used in Europe since 2007, and a wealth of data has been collected. These studies and reports indicate that the efficacy and safety profiles of biosimilar epoetin are similar to those of originator epoetin alfa. Biosimilars of epoetin alfa are expected to be among the first biosimilar agents to be approved for use in the United States. The availability of lower cost epoetins may have significant impact on the treatment of anemia of chronic kidney disease.
生物制剂，包括促红细胞生成素，在治疗各种疾病中继续发挥重要作用。然而，生物制剂价格昂贵，而且很快这些药物的许多专利都将到期，为非品牌产品（即生物类似药）腾出了空间。只有通过向市场引入竞争，成本才会降低。在欧洲，自 2005 年以来，一直有一个专门的监管途径来批准生物类似药。美国食品和药物管理局（FDA）也制定了类似的审查途径。这些批准生物类似药的指南非常严格，需要进行临床前药效学和毒理学研究、临床研究以证明生物等效性和疗效，以及长期上市后研究以监测药物安全性。自 2007 年以来，欧洲一直在使用生物类似促红细胞生成素，并且已经收集了大量数据。这些研究和报告表明，生物类似促红细胞生成素的疗效和安全性与原研促红细胞生成素阿尔法相似。预计促红细胞生成素阿尔法的生物类似药将是首批在美国获得批准使用的生物类似药之一。较低成本的促红细胞生成素的出现可能会对慢性肾脏病贫血的治疗产生重大影响。
