Pharmacokinetics and safety of candidate tocilizumab biosimilar CT-P47 administered by auto-injector or pre-filled syringe: a randomized, open‑label, single-dose phase I study-Reference-Cited by-同舟云学术

Pharmacokinetics and safety of candidate tocilizumab biosimilar CT-P47 administered by auto-injector or pre-filled syringe: a randomized, open‑label, single-dose phase I study

Published:2024-06-21 Issue:7 Volume:24 Page:681-689
ISSN:1471-2598
Container-title:Expert Opinion on Biological Therapy
language:en
Short-container-title:Expert Opinion on Biological Therapy

Author:

Yu Kyung-Sang¹^ORCID,Ryu Hyunwook¹^ORCID,Shin Dongseong²^ORCID,Park MinKyu³^ORCID,Hwang JunGi³^ORCID,Moon Seol Ju⁴^ORCID,Kim Min-Gul⁴^ORCID,Keystone Edward⁵^ORCID,Smolen Josef S⁶^ORCID,Kim SungHyun⁷,Bae YunJu⁷,Jeon DaBee⁷,Jang JiYoung⁷,Yang GoEun⁷,Bae JiHun⁷,Lee JaeYong⁷,Burmester Gerd R⁸

Affiliation:

1. Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea

2. Gachon University Gil Medical Center, Incheon, Republic of Korea

3. Chungbuk National University College of Medicine and Hospital, Cheongju, Republic of Korea

4. Jeonbuk National University College of Medicine and Hospital, Jeonbuk, Republic of Korea

5. University of Toronto, Toronto, Ontario, Canada

6. Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, Vienna, Austria

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

8. Charité – Universitätsmedizin Berlin, Berlin, Germany

Funder

Celltrion

Publisher

Informa UK Limited

Link

https://www.tandfonline.com/doi/pdf/10.1080/14712598.2024.2321360

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3. US Food and Drug Administration. Highlights of prescribing information: ACTEMRA (tocilizumab) [Internet]. 2010 [cited 2023 Jul 20]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125276lbl.pdf

4. European Medicines Agency. RoActemra summary of product characteristics [Internet]. 2023 [cited 2023 Jul 14]. Available from: https://www.ema.europa.eu/en/documents/product-information/roactemra-epar-product-information_en.pdf

5. US Food and Drug Administration. Highlights of prescribing information: ACTEMRA (tocilizumab) [Internet]. 2022 [cited 2023 Oct 17]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125472s049lbl.pdf