Population pharmacokinetics of adalimumab biosimilar adalimumab‐adbm and reference product in healthy subjects and patients with rheumatoid arthritis to assess pharmacokinetic similarity-Reference-Cited by-同舟云学术

Population pharmacokinetics of adalimumab biosimilar adalimumab‐adbm and reference product in healthy subjects and patients with rheumatoid arthritis to assess pharmacokinetic similarity

Published:2020-06-11 Issue:11 Volume:86 Page:2274-2285
ISSN:0306-5251
Container-title:British Journal of Clinical Pharmacology
language:en
Short-container-title:Br J Clin Pharmacol

Author:

Kang Jia¹^ORCID,Eudy‐Byrne Rena J.¹^ORCID,Mondick John¹,Knebel William¹,Jayadeva Girish²,Liesenfeld Karl‐Heinz³

Affiliation:

1. Metrum Research Group Tariffville Connecticut USA

2. Boehringer Ingelheim International GmbH Ingelheim Germany

3. Boehringer Ingelheim International GmbH Biberach an der Riss Germany

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1111/bcp.14330

Reference25 articles.

1. 2012 Update of the 2008 American College of Rheumatology recommendations for the use of disease-modifying antirheumatic drugs and biologic agents in the treatment of rheumatoid arthritis

2. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs

3. U.S. Food and Drug Administration.Guidance for Industry: Quality Considerations in demonstrating biosimilarity of a therapeutic protein product to a reference product. Available athttps://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291134.pdf

4. European Medicines Agency.Guideline on similar biological medicinal products containing monoclonal antibodies‐nonclinical and clinical issues. Available athttp://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500128686.pdf

5. Bioequivalence, safety and immunogenicity of BI 695501, an adalimumab biosimilar candidate, compared with the reference biologic in a randomized, double-blind, active comparator phase I clinical study (VOLTAIRE®-PK) in healthy subjects

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