Regulatory considerations on biological products in Brazil;Consideraciones Regulatorias sobre Productos Biológicos en Brasil

Value in Health Regional Issues

Volumn 1, Issue 2, 2012, Pages 254-256

  Vianna Araujo, Denizar ^a  

^a STATE UNIVERSITY OF RIO DE JANEIRO   (Brazil)

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL PRODUCT; BIOSIMILAR AGENT;

ARTICLE; BRAZIL; CONFLICT; DRUG APPROVAL; DRUG MARKETING; GOVERNMENT REGULATION; PATENT; POSTMARKETING SURVEILLANCE; PRACTICE GUIDELINE; PRIORITY JOURNAL; WORLD HEALTH ORGANIZATION;

EID: 84873864303     PISSN: 22121099     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.vhri.2012.09.002     Document Type: Article

References (7)

1. Organização Mundial da Saúde. Diretrizes na avaliação de produtos biológicos similares. Adotado pela 60a reunião do Comitĉ 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: [Accessed August 27, 2012]. http://www.who.int/biologicals/areas/biological_therapeutics/BIOTHERAPEU TICS_FOR_WEB_22APRIL2010.pdf.
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. Joung J., Robertson J.S., Griffiths E., et al. WHO informal consultation on regulatory evaluation of therapeutic biological medicinal products held at WHO Headquarters, Genebra, 19-20 April 2007. Biologicals 2008, 36:269-276.
5. European Medicines Agency. Guideline on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use. Available from: [Accessed August 27, 2012]. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guidelin e/2010/11/WC500099362.pdf.
6. U.S. Food and Drug Administration. FDA issues draft guidance on biosimilar product development Available from: [Accessed August 27, 2012]. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm291232.htm.
7. Centro Latino-Americano e do Caribe de Informação em Ciĉncias da Saúde. Resolução - RDC n 55. Available from: [Accessed August 27, 2012]. http://bvsms.saude.gov.br/bvs/saudelegis/anvisa/2010/anexo/anexo_res0055_16_12_2010.pdf.