Demonstration of Physicochemical and Functional Similarity of the Biosimilar BAT1806/BIIB800 to Reference Tocilizumab-Reference-Cited by-同舟云学术

Demonstration of Physicochemical and Functional Similarity of the Biosimilar BAT1806/BIIB800 to Reference Tocilizumab

Published:2024-06-18 Issue:4 Volume:38 Page:571-588
ISSN:1173-8804
Container-title:BioDrugs
language:en
Short-container-title:BioDrugs

Author:

Liu Yujie,Xie Jianhua,Li Zhuxiang,Mei Xiong,Cao Di,Li Shengfeng,Engle Linda,Liu Suli,Ebbers Hans C.^ORCID,Liu Cuihua^ORCID

Funder

Biogen International GmbH

Publisher

Springer Science and Business Media LLC

Link

https://link.springer.com/content/pdf/10.1007/s40259-024-00662-5.pdf

Reference26 articles.

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3. American College of Rheumatology. Tocilizumab (Actemra). 2023. https://rheumatology.org/patients/tocilizumab-actemra. Accessed 18 Jan 2024.

4. Perrone F, Piccirillo MC, Ascierto PA, Salvarani C, Parrella R, Marata AM, et al. Tocilizumab for patients with COVID-19 pneumonia. The single-arm TOCIVID-19 prospective trial. J Transl Med. 2020;18(1):405–21. https://doi.org/10.1186/s12967-020-02573-9.

5. US Food and Drug Administration. Quality considerations in demonstrating biosimilarity of a therapeutic protein product to a reference product. Guidance for industry. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/quality-considerations-demonstrating-biosimilarity-therapeutic-protein-product-reference-product. Accessed 18 Jan 2024.

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1. Correction to: Demonstration of Physicochemical and Functional Similarity of the Biosimilar BAT1806/BIIB800 to Reference Tocilizumab;BioDrugs;2024-08-22