Physicochemical analysis and biological characterization of FKB327 as a biosimilar to adalimumab-Reference-Cited by-同舟云学术

Physicochemical analysis and biological characterization of FKB327 as a biosimilar to adalimumab

Published:2020-06 Issue:3 Volume:8 Page:
ISSN:2052-1707
Container-title:Pharmacology Research & Perspectives
language:en
Short-container-title:Pharmacol Res Perspect

Author:

Schreiber Stefan¹^ORCID,Yamamoto Katsuhiko²,Muniz Rafael³^ORCID,Iwura Takafumi⁴

Affiliation:

1. Clinic for Internal Medicine Kiel CampusUniversity Hospital Schleswig‐Holstein Kiel Germany

2. Analytical Development Department Fujifilm Kyowa Kirin Biologics Co., Ltd. Tokyo Japan

3. Global Medical Affairs Mylan Inc. Canonsburg PA USA

4. Bio Process Research and Development Laboratories Production Division Kyowa Kirin Co., Ltd. Takasaki Japan

Funder

Fujifilm Corporation

Publisher

Wiley

Subject

General Pharmacology, Toxicology and Pharmaceutics,Neurology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/prp2.604

Reference35 articles.

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4. Analytical tools for characterizing biopharmaceuticals and the implications for biosimilars

5. US Food and Drug Administration.Biological product definitions.www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/UCM581282.pdf. Accessed April 19 2019.

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