Immunogenicity in Clinical Practice and Drug Development: When is it Significant?-Reference-Cited by-同舟云学术

Immunogenicity in Clinical Practice and Drug Development: When is it Significant?

Published:2019-11-25 Issue:2 Volume:13 Page:219-223
ISSN:1752-8054
Container-title:Clinical and Translational Science
language:en
Short-container-title:Clin Transl Sci

Author:

Shakhnovich Valentina¹²,Meibohm Bernd³,Rosenberg Amy⁴,Kierzek Andrzej M.⁵,Hasenkamp Rachel¹,Funk Ryan S.⁶,Thalhauser Craig J.⁷,Graaf Piet H.⁸,Wang Yow‐Ming C.⁹,Hamuro Lora¹⁰

Affiliation:

1. Children's Mercy Kansas City Kansas City Missouri USA

2. University of Missouri Kansas City School of Medicine Kansas City Missouri USA

3. Department of Pharmaceutical Sciences University of Tennessee Health Science Center Memphis Tennessee USA

4. FDA Division of Biotechnology Review and Research III Office of Pharmaceutical Quality Office of Biotechnology Products CDER/FDA Silver Spring Maryland USA

5. Certara Sheffield UK

6. Department of Pharmacy Practice The University of Kansas Kansas City Kansas USA

7. Quantitative Clinical Pharmacology Bristol‐Myers Squibb Princeton New Jersey USA

8. Certara Canterbury UK

9. Office of Clinical Pharmacology OTS/CDER/FDA Silver Spring Maryland USA

10. Clinical Pharmacology & Pharmacometrics Bristol‐Myers Squibb Princeton New Jersey USA

Funder

National Center for Advancing Translational Sciences

Publisher

Wiley

Subject

General Pharmacology, Toxicology and Pharmaceutics,General Biochemistry, Genetics and Molecular Biology,General Medicine,General Neuroscience

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1111/cts.12717

Reference10 articles.

1. Immunogenicity of biologics in inflammatory bowel disease

2. The Impact of Combination Therapy on Infliximab Levels and Antibodies in Children and Young Adults With Inflammatory Bowel Disease

3. Efficacy and safety of the biosimilar ABP 501 compared with adalimumab in patients with moderate to severe rheumatoid arthritis: a randomised, double-blind, phase III equivalence study

4. Phase III Randomized Study of SB 5, an Adalimumab Biosimilar, Versus Reference Adalimumab in Patients With Moderate‐to‐Severe Rheumatoid Arthritis

5. Similar efficacy, safety and immunogenicity of adalimumab biosimilar BI 695501 and Humira reference product in patients with moderately to severely active rheumatoid arthritis: results from the phase III randomised VOLTAIRE‐RA equivalence study;Cohen S.B.;Ann. Rheum. Dis.,2018

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