Presented by Andrew D. Zelenetz, MD, PhD, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York, and Pamela S. Becker, MD, PhD, Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance, Seattle, Washington.
J Natl Compr Canc Netw. 2016 May;14(5 Suppl):626-9. doi: 10.6004/jnccn.2016.0178.
As biologics go off-patent, the field of oncology is grappling with incorporating biosimilars. These are highly similar (but not generic versions of) biologic agents, and they are approved based on showing "near fingerprint identity" in structure and potency. Their introduction is expected to increase competition and lower treatment costs. The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Myeloid Growth Factors has incorporated the first biosimilar approved in the United States, filgrastim-sndz, into its recommendations. At the NCCN 21st Annual Conference, Andrew D. Zelenetz, MD, PhD, provided an overview of biosimilars, describing the process of their development and approval; Pamela S. Becker, MD, PhD, discussed the NCCN Guidelines recommendations for the use of filgrastim-sndz and of tbo-filgrastim, which was approved in the United States as a true biologic agent. The use of tbo-filgrastim can be somewhat confusing, as it does not have the same indications as the other growth factors.
随着生物制剂专利到期，肿瘤学领域正在努力将生物类似药纳入其中。这些药物与生物制剂高度相似（但不是通用版本），它们是基于在结构和效力上显示“近乎指纹一致”而获得批准的。预计它们的引入将增加竞争并降低治疗成本。NCCN 肿瘤学临床实践指南（NCCN 指南）已将在美国获得批准的首个生物类似药 filgrastim-sndz 纳入其建议中。在 NCCN 第 21 届年会上，Andrew D. Zelenetz，医学博士，博士学位，概述了生物类似药的开发和批准过程；Pamela S. Becker，医学博士，博士学位，讨论了 NCCN 指南关于使用 filgrastim-sndz 和 tbo-filgrastim 的建议，后者在美国被批准为真正的生物制剂。tbo-filgrastim 的使用可能有些令人困惑，因为它与其他生长因子的适应症不同。
