Health Canada/BIOTECanada Summit on regulatory and clinical topics related to subsequent entry biologics (biosimilars), Ottawa, Canada, 14 May 2012

Author:

Kay Jonathan,Feagan Brian G.,Guirguis Micheal S.,Keystone Edward C.,Klein Agnes V.,Lubiniecki Anthony S.,Mould Diane R.,Nyarko Kwasi A.,Ridgway Anthony A.G.,Trudeau Maureen E.,Wang Jian

Publisher

Elsevier BV

Subject

Pharmacology,General Immunology and Microbiology,Applied Microbiology and Biotechnology,General Medicine,Bioengineering,Biotechnology

Reference44 articles.

1. Next generation and biosimilar monoclonal antibodies: essential considerations towards regulatory acceptance in Europe. February 3–4, 2011, Freiburg, Germany;Reichert;MAbs,2011

2. WHO/KFDA joint workshop on implementing WHO guidelines on evaluating similar biotherapeutic products, Seoul, Republic of Korea 24–26 August, 2010;Wadhwa;Biologicals,2011

3. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues. EMEA/CHMP/BWP/49348/2005;Committee for Medicinal Products for Human Use, European Medicines Agency,2006

4. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. EMEA/CHMP/BMWP/42832/2005;Committee for Medicinal Products for Human Use, European Medicines Agency,2006

5. Guidelines on evaluation of similar biotherapeutic products (SBP);World Health Organization,2009

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