The US Oncology Network; and McKesson Specialty Health, The Woodlands, TX.
J Oncol Pract. 2017 Sep;13(9_suppl):24s-31s. doi: 10.1200/JOP.2017.025734.
In 2015, the United States Food and Drug Administration (FDA) approved the first biosimilar, filgrastim-sndz, a biosimilar of the granulocyte colony-stimulating factor filgrastim. Since that time, the FDA has approved four additional biosimilar tumor necrosis factor α inhibitors, and, in May 2017, the Oncology Drug Advisory Committee voted in favor of approval of an epoetin alfa biosimilar. The patents of several widely used biologic cancer therapies (including trastuzumab, rituximab, bevacizumab, cetuximab, and pegfilgrastim) are recently expired or due to expire in the near future, so the introduction of biosimilars into the oncology treatment armamentarium is imminent. However, their arrival also will introduce challenges, including pharmacy and supply chain management and the need for education of clinicians and patients about the efficacy and safety of these agents. These considerations, along with an overview of biosimilars in the oncology pipeline, will be discussed in this review.
2015 年，美国食品和药物管理局（FDA）批准了首个生物类似药——filgrastim-sndz，这是粒细胞集落刺激因子 filgrastim 的生物类似药。自那时以来，FDA 已经批准了另外四种肿瘤坏死因子 α 抑制剂生物类似药，并且在 2017 年 5 月，肿瘤药物咨询委员会投票赞成批准一种 epoetin alfa 生物类似药。几种广泛使用的生物癌症疗法（包括曲妥珠单抗、利妥昔单抗、贝伐单抗、西妥昔单抗和 pegfilgrastim）的专利最近已经过期或即将在不久的将来过期，因此生物类似药即将被引入肿瘤治疗领域。然而，它们的到来也将带来挑战，包括药房和供应链管理，以及需要对临床医生和患者进行关于这些药物的疗效和安全性的教育。在本次综述中，将讨论这些考虑因素以及肿瘤领域生物类似药的概述。
