Biosimilar: what it is not-Reference-Cited by-同舟云学术

Biosimilar: what it is not

Published:2015-06-04 Issue:5 Volume:80 Page:949-956
ISSN:0306-5251
Container-title:British Journal of Clinical Pharmacology
language:en
Short-container-title:Br J Clin Pharmacol

Author:

de Mora Fernando¹^ORCID

Affiliation:

1. Department of Pharmacology, Therapeutics and Toxicology; Universitat Autònoma de Barcelona; Barcelona Spain

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1111/bcp.12656/fullpdf

Reference40 articles.

1. European Commission Directive 2003/63/EC amending Directive 2001/83/EC of the European Parliament and of the Council, on the Community code relating to medicinal products for human use

2. EMA Guideline on similar biological medicinal products. CHMP/437/04

3. Section 351(k) of the Public Health Service Act as amended by the Patient Protection and Affordable Care Act under the Biologics Price Competition and Innovation (BPCI) Act (USA) 2010

4. Guideline on similar biological medicinal products 2014

5. Biosimilars: what clinicians should know;Weise;Blood,2012

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