Biosimilarity of HS-20090 to Denosumab in healthy Chinese subjects: a randomized, double-blinded, pharmacokinetics/pharmacodynamics study-Reference-Cited by-同舟云学术

Biosimilarity of HS-20090 to Denosumab in healthy Chinese subjects: a randomized, double-blinded, pharmacokinetics/pharmacodynamics study

Published:2022-09-16 Issue:10 Volume:31 Page:1125-1132
ISSN:1354-3784
Container-title:Expert Opinion on Investigational Drugs
language:en
Short-container-title:Expert Opinion on Investigational Drugs

Author:

Lin Yaqi¹²,Yang Heng³,Yang Xiaoyan¹,Guo Can¹,Yang Shuang¹,Yang Guoping¹,Wu Qiong⁴,Pan Chao⁴,Sun Changan⁴,Li Chuan⁴,He Liangliang⁴,Huang Jie¹,Pei Qi²

Affiliation:

1. Center of Clinical Pharmacology, the Third Xiangya Hospital, Central South University, Changsha, China

2. Department of Pharmacy, the Third Xiangya Hospital, Central South University, Changsha, China

3. Department of Neurology, the Third Xiangya Hospital, Central South University, Changsha, China

4. Department of Hansoh Medical Development Group, Hansoh Pharmaceutical Group Co. Ltd, Shanghai, China

Funder

Hunan Provincial Natural Science Foundation of China

The Key Research and Development Project of Hunan Province

Publisher

Informa UK Limited

Subject

Pharmacology (medical),Pharmacology,General Medicine

Link

https://www.tandfonline.com/doi/pdf/10.1080/13543784.2022.2123737

Reference17 articles.

1. US Food and Drug Administration. Scientific considerations in demonstrating biosimilarity to a reference product. 2015 cited 2022 Jun 1]. Available from 2022 Jun 1: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm291128.pdf

2. Maintaining consistent quality and clinical performance of biopharmaceuticals

3. Agency EM. Guideline on similar biological medicinal products. 2014 cited 2022 Jun 1. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/10/WC500176768.pdf

4. Improving Access to Cancer Treatments: The Role of Biosimilars

5. Denosumab and bisphosphonates: Different mechanisms of action and effects

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