A phase I, randomized, double-blind, single-dose pharmacokinetic study to evaluate the biosimilarity of SB16 (proposed denosumab biosimilar) with reference denosumab in healthy male subjects-Reference-Cited by-同舟云学术

A phase I, randomized, double-blind, single-dose pharmacokinetic study to evaluate the biosimilarity of SB16 (proposed denosumab biosimilar) with reference denosumab in healthy male subjects

Published:2023-10-03 Issue:10 Volume:32 Page:959-966
ISSN:1354-3784
Container-title:Expert Opinion on Investigational Drugs
language:en
Short-container-title:Expert Opinion on Investigational Drugs

Author:

Lee Hyun A.¹^ORCID,Kim Sujung¹^ORCID,Seo Hyoryeong²,Kim Soyeon³

Affiliation:

1. Clinical Developement Group, Samsung Bioepis Co. Ltd, Incheon, Republic of Korea

2. Biometrics Group, Samsung Bioepis Co. Ltd, Incheon, Republic of Korea

3. Clinical Bioanalysis Group, Samsung Bioepis Co. Ltd, Incheon, Republic of Korea

Funder

Samsung Bioepis Co., Ltd

Publisher

Informa UK Limited

Subject

Pharmacology (medical),Pharmacology,General Medicine

Link

https://www.tandfonline.com/doi/pdf/10.1080/13543784.2023.2273510

Reference15 articles.

1. US Food and Drug Administration. Scientific considerations in demonstrating biosimilarity to a reference product: guidance for industry. 2015. https://www.fda.gov/media/82647/download

2. European Medicines Agency. Guideline on similar biological medicinal product. 2014. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-similar-biological-medicinal-products-rev1_en.pdf

3. The cost savings of biosimilars can help increase patient access and lift the financial burden of health care systems

4. US Food and Drug Administration. Prolia: clinical pharmacology and biopharmaceutics review(s). 2010. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/125320s000clinpharmr.pdf

5. Recent Advances in Translational Pharmacokinetics and Pharmacodynamics Prediction of Therapeutic Antibodies Using Modeling and Simulation