1. Organização Mundial da Saúde. Diretrizes na avaliação de produtos biológicos similares. Adotado pela 60a reunião do Comitê de Especialistas para a Padronização Biológica da OMS, Genebra 2009.
2. World Health Organization [Internet]. Geneva: WHO guidelines on evaluation of similar biotherapeutic products (SBPs). Available from: http://www.who.int/biologicals/areas/biological_therapeutics/BIOTHERAPEUTICS_FOR_WEB_22APRIL2010.pdf. [Accessed August 27, 2012].
3. Requirements for the use of animal cells as in vitro substrates for the production of biologicals. In: WHO Expert Committee on Biological Standardization. Forty-seventh report. Genebra, World Health Organization, 1998, Annex 1 (WHO Technical Report Series, No. 878).
4. WHO informal consultation on regulatory evaluation of therapeutic biological medicinal products held at WHO Headquarters, Genebra, 19-20 April 2007;Joung;Biologicals,2008
5. European Medicines Agency. Guideline on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/11/WC500099362.pdf. [Accessed August 27, 2012].