An update on the clinical evidence that supports biosimilar approvals in Europe-Reference-Cited by-同舟云学术

An update on the clinical evidence that supports biosimilar approvals in Europe

Published:2018-04-27 Issue:7 Volume:84 Page:1415-1431
ISSN:0306-5251
Container-title:British Journal of Clinical Pharmacology
language:en
Short-container-title:Br J Clin Pharmacol

Author:

Mielke Johanna¹^ORCID,Jilma Bernd²,Jones Byron¹,Koenig Franz³

Affiliation:

1. Statistical Methodology; Novartis Pharma AG; 4056 Basel Switzerland

2. Department of Clinical Pharmacology; Medical University of Vienna; Waehringer Guertel 18-20 1090 Vienna Austria

3. Center for Medical Statistics, Informatics and Intelligent Systems; Medical University of Vienna; Spitalgasse 23 1090 Vienna Austria

Funder

Austrian Science Fund

H2020 Marie Skłodowska-Curie Actions

Swiss State Secretariat for Education, Research and Innovation

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1111/bcp.13586/fullpdf

Reference86 articles.

1. Pharmaceutical evaluation of biosimilars: important differences from generic low-molecular-weight pharmaceuticals;Crommelin;Eur J Hosp Pharm Sci,2005

2. CHMP Guideline on similar biological medicinal products (revision 1) 2014 http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/10/WC500176768.pdf

3. Biosimilar: what it is not;Mora;Br J Clin Pharmacol,2015

4. EMA Questions and answers on biosimilar medicines (similar biological medicinal products) 2012 http://www.medicinesforeurope.com/wp-content/uploads/2016/03/WC500020062.pdf

5. Japanese regulation of biosimilar products: past experience and current challenges;Arato;Br J Clin Pharmacol,2016

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