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Open Access 01-10-2019 | Letter to the Editor

Comment on “Analysis of Pharmacokinetic and Pharmacodynamic Parameters in EU-Versus US-Licensed Reference Biological Products: Are In Vivo Bridging Studies Justified for Biosimilar Development?”

Authors: Christopher J. Webster, Gillian R. Woollett

Published in: BioDrugs | Issue 5/2019

Excerpt

Dear Editor, …

Webster CJ, Woollett GR. A ‘global reference’ comparator for biosimilar development. BioDrugs. 2017;31(4):279–86. https://doi.org/10.1007/s40259-017-0227-4.CrossRefPubMedPubMedCentral

Tu C-L, Wang Y-L, Hu T-M, Hsu L-F. Analysis of pharmacokinetic and pharmacodynamic parameters in EU versus US-licensed reference biological products: are in vivo bridging studies justified for biosimilar development? BioDrugs. 2019;33(4):437–46. https://doi.org/10.1007/s40259-019-00357-2.CrossRefPubMed

Guidance for industry: quality considerations in demonstrating biosimilarity of a therapeutic protein product to a reference product. US Food and Drug Administration. 2015. p. 9.

Committee for Medicinal Products for Human Use (CHMP): guideline on similar biological medicinal products CHMP/437/04 Rev 1, October 2014, Section 3.2.

Title: Comment on “Analysis of Pharmacokinetic and Pharmacodynamic Parameters in EU-Versus US-Licensed Reference Biological Products: Are In Vivo Bridging Studies Justified for Biosimilar Development?”
Authors: Christopher J. Webster
Gillian R. Woollett
Publication date: 01-10-2019
Publisher: Springer International Publishing
Published in: BioDrugs / Issue 5/2019
Print ISSN: 1173-8804
Electronic ISSN: 1179-190X
DOI: https://doi.org/10.1007/s40259-019-00372-3

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Comment on “Analysis of Pharmacokinetic and Pharmacodynamic Parameters in EU-Versus US-Licensed Reference Biological Products: Are In Vivo Bridging Studies Justified for Biosimilar Development?”

Excerpt

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Excerpt

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