Although complex, biologic agents are key components of modern therapy in multiple disciplines, particularly oncology. However, despite the fact that biosimilars (eg, filgrastim-sndz, bevacizumab-awwb, trastuzumab-dkst, rituximab-abbs) have been approved in the United States, many clinicians are poorly informed about their unique pathway for approval. At the NCCN 2019 Annual Congress: Hematologic Malignancies, Dr. Andrew D. Zelenetz, Memorial Sloan Kettering Cancer Center, outlined important issues regarding the use of biosimilars, including extrapolation, interchangeability, and naming.

译文

:尽管复杂,但生物制剂是现代疗法在多个学科(尤其是肿瘤学)中的关键组成部分。然而,尽管在美国已经批准了生物仿制药(例如非格司亭-sndz,贝伐单抗-awwb,曲妥珠单抗-dkst,利妥昔单抗),但许多临床医生对其独特的批准途径知之甚少。在NCCN 2019年会上:血液系统恶性肿瘤,纪念斯隆·凯特琳癌症中心的Andrew D.Zelenetz博士概述了有关生物仿制药使用的重要问题,包括推断,互换性和命名。

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