Clinical comparability and European biosimilar regulations-Reference-Cited by-同舟云学术

Clinical comparability and European biosimilar regulations

Published:2010-01 Issue:1 Volume:28 Page:28-31
ISSN:1087-0156
Container-title:Nature Biotechnology
language:en
Short-container-title:Nat Biotechnol

Author:

Schellekens Huub,Moors Ellen

Publisher

Springer Science and Business Media LLC

Subject

Biomedical Engineering,Molecular Medicine,Applied Microbiology and Biotechnology,Bioengineering,Biotechnology

Link

http://www.nature.com/articles/nbt0110-28.pdf

Reference34 articles.

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2. European Parliament and Council. Off. J. Eur. Union 47, 34–57 (2004).

3. Anonymous. Guideline on similar biological medicinal products. (EMEA, London, 2005; accessed 4 March 2008). < http://www.emea.europa.eu/pdfs/human/biosimilar/043704en.pdf >

4. Anonymous. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues. (EMEA, London, 2006; accessed 4 March 2008). < http://www.emea.europa.eu/pdfs/human/biosimilar/4934805en.pdf >

5. Anonymous. ANNEX to guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues guidance on similar medicinal products containing recombinant erythropoietins. (EMEA, London, 2006; accessed 4 March 2008). < http://www.emea.europa.eu/pdfs/human/biosimilar/9452605en.pdf >

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