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Volumn 1, Issue 2, 2012, Pages 228-234

Potential Regulatory and Commercial Environment for Biosimilars in Latin America

Author keywords

Biosimilar pharmaceuticals; Drug industry; Drug legislation; Latin America

Indexed keywords

BIOSIMILAR AGENT; LOW MOLECULAR WEIGHT HEPARIN; MONOCLONAL ANTIBODY; PEGINTERFERON;

EID: 84870921310     PISSN: 22121099     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.vhri.2012.09.015     Document Type: Article
Times cited : (34)

References (10)
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    • Castanheira, L.G.1    Barbano, D.B.2    Rech, N.3
  • 3
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    • Expert Committee on Biological Standardization
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    • Biologics and biosimilars in Brazil: regulatory outlook and pharmacoeconomic challenges.
    • Mexico City, Mexico, September 10
    • Pinto V. Biologics and biosimilars in Brazil: regulatory outlook and pharmacoeconomic challenges. In: ISPOR 3rd Latin America Conference. Mexico City, Mexico, September 10, 2011.
    • (2011) ISPOR 3rd Latin America Conference
    • Pinto, V.1
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    • Federal Drug Administration. Scientific Considerations in Demonstrating Biosimilarity to a Reference Product - Draft Guidance.
    • Rockville, MD: U.S. Department of Health and Human Services, February
    • Federal Drug Administration. Scientific Considerations in Demonstrating Biosimilarity to a Reference Product - Draft Guidance. Rockville, MD: U.S. Department of Health and Human Services, February 2012.
    • (2012)
  • 6
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    • Milenio. Medicamento biotecnológico del ISSSTE desata pleito legal
    • Available from: [Accessed June 14, 2012].
    • Milenio. Medicamento biotecnológico del ISSSTE desata pleito legal. Available from: [Accessed June 14, 2012]. http://jalisco.milenio.com/cdb/doc/impreso/9043982.
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    • Milenio. Firma Calderón regulación para medicamentos biotecnológicos
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    • Milenio. Firma Calderón regulación para medicamentos biotecnológicos. Available from: [Accessed June 6, 2012]. http://www.milenio.com/cdb/doc/noticias2011/a651c69e0f2e1c7955fbbca5a8ff2d9d.
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    • Institio de Salud Publica
    • Available from: [Accessed June 7, 2012].
    • Institio de Salud Publica. Gobierno anuncia mesa de trabajo para regular medicamentos biotecnológicos. Available from: [Accessed June 7, 2012]. http://www.ispch.cl/noticia/14038/gobierno-anuncia-mesa-de-trabajo-para-regular-medicamentos-biotecnologicos.
    • Gobierno anuncia mesa de trabajo para regular medicamentos biotecnológicos
  • 9
    • 84870946831 scopus 로고    scopus 로고
    • Cooperativa. Polémica por insulina india tiene origen comercial
    • Según director de Asilfa. Available from: [Accessed June 8, 2012].
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  • 10
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    • Argentina Investiga. La Universidad desarrollará medicamentos contra el cáncer
    • Available from: [Accessed June 11, 2012].
    • Argentina Investiga. La Universidad desarrollará medicamentos contra el cáncer. Available from: [Accessed June 11, 2012]. http://argentinainvestiga.edu.ar/english/noticia.php?titulo=the_university_will_develop_medicines_to_treat_cancer&id=1269.


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.