Internistische Onkologie der Thoraxtumoren, Thoraxklinik im Universitatsklinikum Heidelberg, Translational Lung Research Center, Heidelberg, Germany.
Department of Medical Oncology, School of Cancer and Imaging Sciences, University of Manchester, Christie Hospital, Manchester, UK.
Immunotherapy. 2019 Oct;11(15):1337-1351. doi: 10.2217/imt-2019-0125. Epub 2019 Sep 26.
ABP 215 (MVASI™) is the first approved biosimilar to Avastin (bevacizumab). It is approved in the USA and the European Union (EU) for all bevacizumab indications in these jurisdictions except for ovarian cancer in the USA due to orphan drug exclusivity. ABP 215 was shown to be structurally, functionally and clinically (pharmacokinetic, efficacy and safety) similar to the bevacizumab reference product; the pharmacokinetic study was conducted in healthy adult men (n = 202); safety and efficacy were evaluated in patients with advanced nonsquamous non-small-cell lung cancer (n = 642). Together, these results comprise the totality of evidence that provides scientific justification for extrapolation to all approved indications of the reference product and supports the clinical value of ABP 215 as an additional treatment option.
ABP 215（MVASI™）是首个获批的贝伐珠单抗生物类似药。该药已在美国和欧盟获批，除美国卵巢癌外，可用于所有获批适应证，其获批是基于孤儿药的独占性。研究显示，ABP 215 在结构、功能和临床方面（药代动力学、疗效和安全性）与贝伐珠单抗参比制剂相似；药代动力学研究在健康成年男性中开展（n=202）；安全性和疗效在晚期非鳞状非小细胞肺癌患者中评估（n=642）。这些结果构成了证据整体，为参照产品所有获批适应证的外推提供了科学依据，并支持 ABP 215 作为额外治疗选择的临床价值。
