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-Reference-Cited by-同舟云学术

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

Published:2020-06-27 Issue:7 Volume:29 Page:755-762
ISSN:1354-3784
Container-title:Expert Opinion on Investigational Drugs
language:en
Short-container-title:Expert Opinion on Investigational Drugs

Author:

Wang Jiaxue¹²^ORCID,Niu Suping³,Dong Wenliang¹²,Wei Li⁴,Ou Lun⁵,Zhang Tan¹,Zhang Liangbi⁶,Nie Xiaoyan²,Wang Qian¹,Shen Tiantian¹⁷,Wang Qi¹²,Xia Lin¹⁷,Liu Gang¹,Jin Jiting⁶,Zheng Qingshan⁸,Song Haifeng⁹,Fang Yi¹^ORCID

Affiliation:

1. Department of Pharmacy, Peking University People’s Hospital, Beijing, China

2. Department of Pharmacy Administration and Clinical Pharmacy, School of Pharmaceutical, Peking University, Beijing, China

3. Department of Science and Research, Peking University People’s Hospital, Beijing, China

4. Anhui Province Key Laboratory of Gene Engineering Pharmaceutical, Anhui Anke Biotechnology (Group) Co., Ltd., Anhui, China

5. United-Power Pharma Tech Co., Ltd, Beijing, China

6. National and Local Joint Engineering Research Center for Precision Cancer Therapy Technology and Products, Anhui Anke Biotechnology (Group) Co., Ltd, Anhui, China

7. School of Pharmacy, Xuzhou Medical University, Xuzhou, China

8. The Center for Drug Clinical Research of Shanghai University of TCM, Shanghai, China

9. Department of Pharmacology and Toxicology, Beijing Institute of Radiation Medicine, Beijing, China

Funder

Anhui Anke Biotechnology (Group) Co., Ltd

Publisher

Informa UK Limited

Subject

Pharmacology (medical),Pharmacology,General Medicine

Link

https://www.tandfonline.com/doi/pdf/10.1080/13543784.2020.1770226

Reference29 articles.

1. Global Cancer Incidence and Mortality Rates and Trends—An Update

2. The Distinctive Nature of HER2-Positive Breast Cancers

3. FDA; Label of HERCEPTIN ® (trastuzumab) for injection, for intravenous use Initial U.S. Approval; 1998. [cited 2018]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103792s5345lbl.pdf

4. The Global Need for a Trastuzumab Biosimilar for Patients With HER2-Positive Breast Cancer

5. Concepts and Challenges of Biosimilars in Breast Cancer: The Emergence of Trastuzumab Biosimilars

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