Biosimilars—why terminology matters

Author:

Weise Martina,Bielsky Marie-Christine,De Smet Karen,Ehmann Falk,Ekman Niklas,Narayanan Gopalan,Heim Hans-Karl,Heinonen Esa,Ho Kowid,Thorpe Robin,Vleminckx Camille,Wadhwa Meenu,Schneider Christian K

Publisher

Springer Science and Business Media LLC

Subject

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

Reference20 articles.

1. Regulation (EC) 726/2004 of the European Parliament and of the Council. Official J. EU L136/1–L136/33 (2004).

2. Committee for Medicinal Products for Human Use. Biosimilar Guidelines (accessed 20 July 2011); http://www.ema.europa.eu/htms/human/humanguidelines/multidiscipline.htm

3. European Commission. Directive 2001/83/EC Art. 10

4. (4) and Part II of the Annex I of Directive 2001/83/EC, as amended. EudraLex, Volume 1, Pharmaceutical legislation medicinal products for human use (accessed 20 July 2011); http://ec.europa.eu/health/files/eudralex/vol-1/dir_2001_83_cons2009/2001_83_cons2009_en.pdf

5. European Medicines Agency. Guideline on Comparability of Biotechnology-Derived Medicinal Products After a Change in the Manufacturing Process: Non-Clinical and Clinical Issues EMEA/CHMP/BMWP/101695/2006 (EMA, London, 19 July 2007; accessed 20 July 2011) http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003935.pdf

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