메뉴 건너뛰기




Volumn 53, Issue 1, 2013, Pages 127-131

Biosimilars require scientifi cally reliable comparative clinical data

Author keywords

[No Author keywords available]

Indexed keywords

BIOSIMILAR AGENT; GENERIC DRUG; PLACEBO; RECOMBINANT ERYTHROPOIETIN; TUMOR NECROSIS FACTOR ALPHA INHIBITOR;

EID: 84876470598     PISSN: 04825004     EISSN: None     Source Type: Journal    
DOI: 10.1590/S0482-50042013000100013     Document Type: Letter
Times cited : (11)

References (10)
  • 1
    • 82955206455 scopus 로고    scopus 로고
    • Opinião de uma amostra de reumatologistas brasileiros sobre biossimilares
    • Azevedo VF, Felippe LR, Machado DM. Opinião de uma amostra de reumatologistas brasileiros sobre biossimilares. Rev Bras Reumatol 2011; 51(6):.662-71.
    • (2011) Rev Bras Reumatol , vol.51 , Issue.6 , pp. 662-671
    • Azevedo, V.F.1    Felippe, L.R.2    Machado, D.M.3
  • 2
    • 78049362302 scopus 로고    scopus 로고
    • Guidelines on Evaluation of Similar Biotherapeutic Products (SBPs)
    • World Health Organization. Available from:
    • World Health Organization. Guidelines on Evaluation of Similar Biotherapeutic Products (SBPs), 2010. Available from: http://www.who.int/biologicals/areas/biological_therapeutics/BIOTHERAPEUTICS_FOR_WEB_22APRIL2010.pdf
    • (2010)
  • 3
    • 84920590444 scopus 로고    scopus 로고
    • Guidelines on evaluation of Similar Biotherapeutic Products (SBPs)
    • Expert committee on biological standardization Geneva, 19 to 23 October
    • Expert committee on biological standardization Geneva, 19 to 23 October 2009. Guidelines on evaluation of Similar Biotherapeutic Products (SBPs).Adopted by the 60th meeting of the WHO Expert Committee on Biological Standardization.
    • (2009) Adopted by the 60th meeting of the WHO Expert Committee on Biological Standardization.
  • 4
    • 84876458377 scopus 로고    scopus 로고
    • Registro de Produtos Biológicos
    • ANVISA. Available from:
    • ANVISA. Registro de Produtos Biológicos. Baes Legais e Guias - Coletânea. Resolução - RDC n 55, de 16 de dezembro de 2010. Available from: http://portal.anvisa.gov.br/wps/wcm/connect/935aed0048bd2755a7cdaf9a6e94f0d0/Registro_Produtos_Biologicos_Hemoterapicos_10102011_WEB.pdf?MOD=AJPERES.
    • (2010) Baes Legais e Guias - Coletânea. Resolução - RDC n 55, de 16 de dezembro de
  • 5
    • 84860407952 scopus 로고    scopus 로고
    • Current development in regulation of similar biotherapeutic products in Brazil
    • Castanheira LG, Barbano DB, Rech N. Current development in regulation of similar biotherapeutic products in Brazil. Biologicals; 2011; 39(5):308-11.
    • (2011) Biologicals; , vol.39 , Issue.5 , pp. 308-311
    • Castanheira, L.G.1    Barbano, D.B.2    Rech, N.3
  • 6
    • 80053567603 scopus 로고    scopus 로고
    • Biosimilars clinical development program: confirmatory clinical trials: a virtual/simulated case study comparing equivalence and non-inferiority approaches
    • Fletcher MP. Biosimilars clinical development program: confirmatory clinical trials: a virtual/simulated case study comparing equivalence and non-inferiority approaches. Biologicals 2011; 39(5):270-7.
    • (2011) Biologicals , vol.39 , Issue.5 , pp. 270-277
    • Fletcher, M.P.1
  • 7
    • 80053562561 scopus 로고    scopus 로고
    • Statistical considerations for confi rmatory clinical trials for similar biotherapeutic products
    • Njue C. Statistical considerations for confi rmatory clinical trials for similar biotherapeutic products. Biologicals 2011; 39(5):266-9.
    • (2011) Biologicals , vol.39 , Issue.5 , pp. 266-269
    • Njue, C.1
  • 8
    • 33644792767 scopus 로고    scopus 로고
    • Reporting of non inferiority and equivalence randomized trials: an extension of the CONSORT statement
    • CONSORT Group.
    • Piaggio G, Elbourne DR, Altman DG, Pocock SJ, Evans SJ, CONSORT Group. Reporting of non inferiority and equivalence randomized trials: an extension of the CONSORT statement. JAMA 2006; 295:1152-60.
    • (2006) JAMA , vol.295 , pp. 1152-1160
    • Piaggio, G.1    Elbourne, D.R.2    Altman, D.G.3    Pocock, S.J.4    Evans, S.J.5
  • 10
    • 84876494964 scopus 로고    scopus 로고
    • Eritropoietina Humana Recombinante - Monografia do produto
    • Available from:, Accessed on Feb 28
    • Bio-Manguinhos, Fundação Oswaldo Cruz. Eritropoietina Humana Recombinante - Monografia do produto. Available from: http://www.fi ocruz.br/bio_eng/media/monografi a_epo.pdf. Accessed on Feb 28, 2012.
    • (2012)
    • Manguinhos, B.1    Cruz, F.O.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.