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Expert Opinion on Investigational Drugs Volume 29, 2020 - Issue 7
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Original Research

A randomized phase I clinical trial comparing the pharmacokinetic, safety, and immunogenicity of potential biosimilar recombinant human HER2 monoclonal antibody for injection and trastuzumab in healthy Chinese adults

Jiaxue Wanga Department of Pharmacy, Peking University People’s Hospital, Beijing, China;b Department of Pharmacy Administration and Clinical Pharmacy, School of Pharmaceutical, Peking University, Beijing, ChinaORCID Iconhttps://orcid.org/0000-0002-9789-034XView further author information
ORCID Icon,
Suping Niuc Department of Science and Research, Peking University People’s Hospital, Beijing, ChinaView further author information
,
Wenliang Donga Department of Pharmacy, Peking University People’s Hospital, Beijing, China;b Department of Pharmacy Administration and Clinical Pharmacy, School of Pharmaceutical, Peking University, Beijing, ChinaView further author information
,
Li Weid Anhui Province Key Laboratory of Gene Engineering Pharmaceutical, Anhui Anke Biotechnology (Group) Co., Ltd., Anhui, ChinaView further author information
,
Lun Oue United-Power Pharma Tech Co., Ltd, Beijing, ChinaView further author information
,
Tan Zhanga Department of Pharmacy, Peking University People’s Hospital, Beijing, ChinaView further author information
,
Liangbi Zhangf National and Local Joint Engineering Research Center for Precision Cancer Therapy Technology and Products, Anhui Anke Biotechnology (Group) Co., Ltd, Anhui, ChinaView further author information
,
Xiaoyan Nieb Department of Pharmacy Administration and Clinical Pharmacy, School of Pharmaceutical, Peking University, Beijing, ChinaView further author information
,
Qian Wanga Department of Pharmacy, Peking University People’s Hospital, Beijing, ChinaView further author information
,
Tiantian Shena Department of Pharmacy, Peking University People’s Hospital, Beijing, China;g School of Pharmacy, Xuzhou Medical University, Xuzhou, ChinaView further author information
,
Qi Wanga Department of Pharmacy, Peking University People’s Hospital, Beijing, China;b Department of Pharmacy Administration and Clinical Pharmacy, School of Pharmaceutical, Peking University, Beijing, ChinaView further author information
,
Lin Xiaa Department of Pharmacy, Peking University People’s Hospital, Beijing, China;g School of Pharmacy, Xuzhou Medical University, Xuzhou, ChinaView further author information
,
Gang Liua Department of Pharmacy, Peking University People’s Hospital, Beijing, ChinaView further author information
,
Jiting Jinf National and Local Joint Engineering Research Center for Precision Cancer Therapy Technology and Products, Anhui Anke Biotechnology (Group) Co., Ltd, Anhui, ChinaView further author information
,
Qingshan Zhengh The Center for Drug Clinical Research of Shanghai University of TCM, Shanghai, ChinaView further author information
,
Haifeng Songi Department of Pharmacology and Toxicology, Beijing Institute of Radiation Medicine, Beijing, ChinaView further author information
&
Yi Fanga Department of Pharmacy, Peking University People’s Hospital, Beijing, ChinaCorrespondence[email protected]
ORCID Iconhttps://orcid.org/0000-0002-3547-5829View further author information
ORCID Icon show all
Pages 755-762 | Received 21 Feb 2020, Accepted 13 May 2020, Published online: 27 Jun 2020

Citations (6)

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Guangwen Liu, Zhongnan Xu, Wei Yang, Jinling Xue, Yanli Wang, Zhengzhi Liu, Yingzi Cui, Xinyao Qu, Tianying Chang, Shuang Yu, Yang Cheng, Yannan Zhou, Jiahui Chen, Qing Ren, Wanhua Wang, Qiaohuan Deng, Zeyu Wang & Haimiao Yang. (2022) A randomized, double-blind, single-dose, single-center, parallel phase I clinical study comparing the pharmacokinetics, immunogenicity, safety, and tolerance of pertuzumab injection and Perjeta® in healthy Chinese male subjects. Expert Opinion on Biological Therapy 22:2, pages 187-195.
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Wenliang Dong, Min Chen, Suping Niu, Bianzhen Wang, Lin Xia, Jiaxue Wang, Tiantian Shen, Qian Wang, Jie Lv, Gang Liu, Huaying Fan, Zhenwei Xie, Fan Xie, Youzhong an, Qingshan Zheng, Huiying Rao, Haifeng Song & Yi Fang. (2022) Pharmacokinetic bioequivalence, safety, and immunogenicity of GB222, a bevacizumab biosimilar candidate, and bevacizumab in Chinese healthy males: a randomized clinical trial. Expert Opinion on Biological Therapy 22:2, pages 253-262.
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Articles from other publishers (4)

Lyudmila U. Sarder & Sarfraz Ahmad. (2023) Emerging role of biosimilars: Focus on trastuzumab and metastatic human epidermal growth factor receptor 2-positive breast cancer. Results in Chemistry 6, pages 101055.
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Huahua Pu, Jingying Jia, Chunyang Zhao, Sheng Hou, Huaizu Guo, Jing Li, Weizhu Qian, Hao Wang, Chan Sun & Yang Zou. (2022) A Randomized, Single‐dose, Phase I Clinical Comparison of a Trastuzumab Biosimilar With a Reference Trastuzumab Formulation in Healthy Chinese Male Volunteers. Clinical Pharmacology in Drug Development 12:2, pages 181-189.
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Lobna Abdel Aziz Kilany, Ayman Abdel Samie Gaber, Mohammad Mabrouk Aboulwafa & Hamdallah Hafez Zedan. (2021) Trastuzumab immunogenicity development in patients’ sera and in laboratory animals. BMC Immunology 22:1.
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Yingzi Cui, Dongyang Cui, Xinran Ren, Xuesong Chen, Guangwen Liu, Zhengzhi Liu, Yanli Wang, Xinyao Qu, Yicheng Zhao & Haimiao Yang. (2021) Pharmacokinetics, Immunogenicity and Safety Study for SHR-1309 Injection and Perjeta® in Healthy Chinese Male Volunteers. Frontiers in Pharmacology 12.
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