A randomized, double-blind, single-dose, phase 1 study comparing the pharmacokinetics, pharmacodynamics, safety, and immunogenicity of denosumab biosimilar CT‑P41 and reference denosumab in healthy males-Reference-Cited by-同舟云学术

A randomized, double-blind, single-dose, phase 1 study comparing the pharmacokinetics, pharmacodynamics, safety, and immunogenicity of denosumab biosimilar CT‑P41 and reference denosumab in healthy males

Published:2024-02-22 Issue:7 Volume:24 Page:655-663
ISSN:1471-2598
Container-title:Expert Opinion on Biological Therapy
language:en
Short-container-title:Expert Opinion on Biological Therapy

Author:

Kim Anhye¹^ORCID,Hong Jang Hee²^ORCID,Shin Wonsuk¹^ORCID,Yoo Hyounggyoon¹^ORCID,Jung Jin-Gyu²^ORCID,Reginster Jean-Yves³⁴^ORCID,Kim SungHyun⁵,Bae YunJu⁵,Suh JeeHye⁵,Kim Sera⁵,Lee EunKyung⁵,Silverman Stuart⁶⁷^ORCID

Affiliation:

1. Department of Clinical Pharmacology and Therapeutics, CHA University School of Medicine, Seongnam, Republic of Korea

2. Department of Pharmacology, College of Medicine, Chungnam National University, Daejeon, Republic of Korea

3. WHO Collaborating Center for Epidemiology of Musculoskeletal Health and Aging, Liège, Belgium

4. College of Science, Kind Saud University, Riyadh, Kingdom of Saudi Arabia

5. Celltrion, Inc., Incheon, Republic of Korea

6. Department of Medicine, Division of Rheumatology, Cedars-Sinai Medical Center, Los Angeles, CA, USA

7. OMC Clinical Research Center, Beverly Hills, CA, USA

Funder

Celltrion

Publisher

Informa UK Limited

Link

https://www.tandfonline.com/doi/pdf/10.1080/14712598.2024.2316846

Reference19 articles.

1. Denosumab: mechanism of action and clinical outcomes

2. European Medicines Agency. Prolia summary of product characteristics [Internet]. 2023 [cited 2023 Sep 26]. Available from: https://www.ema.europa.eu/en/documents/product-information/prolia-epar-product-information_en.pdf

3. US Food and Drug Administration. Prolia prescribing information [Internet]. 2023 [cited 2023 Nov 3]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125320Orig1s211lbl.pdf

4. Management of patients at very high risk of osteoporotic fractures through sequential treatments

5. Algorithm for the management of patients at low, high and very high risk of osteoporotic fractures

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1. Efficacy and safety of candidate biosimilar CT-P41 versus reference denosumab: a double-blind, randomized, active-controlled, Phase 3 trial in postmenopausal women with osteoporosis;Osteoporosis International;2024-07-23