Immunogenicity of an adalimumab biosimilar, FKB327, and its reference product in patients with rheumatoid arthritis
Author:
Affiliation:
1. University Medicine Berlin Berlin Germany
2. NDA Group Leatherhead UK
3. Hammersmith Medicines Research London UK
4. Fujifilm Kyowa Kirin Biologics Tokyo Japan
5. Mylan Inc Canonsburg PA USA
6. Stanford University Palo Alto CA USA
Funder
Fujifilm Corporation
Publisher
Wiley
Subject
Rheumatology
Link
https://onlinelibrary.wiley.com/doi/pdf/10.1111/1756-185X.13951
Reference23 articles.
1. Quality of Life and Cost Study of Rheumatoid Arthritis Therapy With Biological Medicines
2. Consistency of quality attributes for the glycosylated monoclonal antibody Humira® (adalimumab)
3. US Food and Drug Administration.Biosimilar and interchangeable products.2017.www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm580419.htm. Accessed October 17 2018
4. Pharmacokinetics, safety, tolerability and immunogenicity of FKB327, a new biosimilar medicine of adalimumab/Humira, in healthy subjects
5. Immunogenicity of Biologics in Chronic Inflammatory Diseases: A Systematic Review
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