ABP 980: promising trastuzumab biosimilar for HER2-positive breast cancer.
ABP 980: promising trastuzumab biosimilar for HER2-positive breast cancer.
复制标题
ABP 980：有望用于治疗 HER2 阳性乳腺癌的曲妥珠单抗生物仿制药。
DOI：
10.1080/14712598.2018.1430761
复制
发表时间：
2018
影响因子：
4.6
通讯作者：
Nahta,Rita
中科院分区：
文献类型：
--
作者：
Paplomata,Elisavet;Nahta,Rita
简介：HER2 靶向抗体曲妥珠单抗的批准显着改善了 HER2 阳性乳腺癌患者的预后。包括 ABP 980 在内的多种曲妥珠单抗生物仿制药正处于临床开发阶段。生物仿制药与参考生物仿制药并不相同，但在分析和临床研究中表现出等效性和安全性。涵盖领域：曲妥珠单抗简介、曲妥珠单抗生物仿制药概述以及 ABP 980 临床前和临床研究的详细回顾。我们检索了 PubMed 以及 2016-2017 年 ASCO 和 ESMO 会议记录中的“ABP 980”或“曲妥珠单抗生物仿制药”。使用“ABP 980 和乳腺癌”或“曲妥珠单抗生物仿制药和乳腺癌”在 ClinicalTrials.gov 上搜索 III 期试验。包括 ABP 980 药代动力学 (PK) 或药效学 (PD) 的分析研究、ABP 980 安全性和 PK/PD 的 I 期研究，以及与曲妥珠单抗相比的临床疗效的 III 期研究。 专家意见：关于生物仿制药对总体医疗保健成本的长期影响、多种批准的生物仿制药的保险覆盖范围以及广泛的临床安全性和疗效随访，仍然存在问题。通过创造竞争性市场，曲妥珠单抗生物仿制药预计将改善标准护理治疗的可及性，尽管仍有待获得现实世界的证据。全球范围内 HER2 靶向治疗的普及可能最终会改变乳腺癌的现状和生存率。
Introduction: Approval of the HER2-targeted antibody trastuzumab dramatically improved outcomes for patients with HER2-positive breast cancer. Multiple trastuzumab biosimilars, including ABP 980, are in clinical development. Biosimilars are not identical to the reference biologic, but exhibit equivalence and safety in analytical and clinical studies.Areas covered: A brief introduction to trastuzumab, overview of trastuzumab biosimilars, and detailed review of ABP 980 preclinical and clinical studies are included. We searched PubMed and 2016–2017 ASCO and ESMO conference proceedings for ‘ABP 980’ or ‘trastuzumab biosimilar’. ‘ABP 980 and breast cancer’ or ‘trastuzumab biosimilar and breast cancer’ were used to search clinicaltrials.gov for phase III trials. Analytical studies of ABP 980 pharmacokinetics (PK) or pharmacodynamics (PD), phase I studies of ABP 980 safety and PK/PD, and phase III studies of clinical efficacy vs trastuzumab are included.Expert opinion: Questions remain regarding long-term impact of biosimilars on overall healthcare costs, insurance coverage of multiple approved biosimilars, and extensive clinical safety and efficacy follow-up. By producing a competitive market, trastuzumab biosimilars are anticipated to improve access to standard of care therapies, although real-world evidence remains to be obtained. Increased global access to HER2-targeted therapy may eventually alter the landscape of breast cancer and survival rates.