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Volumn 24, Issue 6, 2014, Pages 1154-1164

Biosimilars: Where we were and where we are

Author keywords

Biosimilars; Regulatory framework; Statistical design

Indexed keywords

BIOLOGICAL PRODUCT; BIOSIMILAR AGENT;

EID: 84910071803     PISSN: 10543406     EISSN: 15205711     Source Type: Journal    
DOI: 10.1080/10543406.2014.941994     Document Type: Article
Times cited : (5)

References (26)
  • 2
    • 84872419787 scopus 로고    scopus 로고
    • Assessing biosimilarity and drug interchangeability of biosimilar products
    • Chow, S. C. (2013a). Assessing biosimilarity and drug interchangeability of biosimilar products. Statistics in Medicine 32:361-363.
    • (2013) Statistics in Medicine , vol.32 , pp. 361-363
    • Chow, S.C.1
  • 20
    • 79953276605 scopus 로고    scopus 로고
    • Health Canada, Ottawa, Canada. Patient Protection and Affordable Care Act (amended by the Health Care and Education Reconciliation Act) (P.L. 111-1148). (2010). United States, March 23, 2010
    • Health Canada. (2010). Guidance for sponsors: Information and submission requirements for subsequent entry biologics (SEBs). Health Canada, Ottawa, Canada. Patient Protection and Affordable Care Act (amended by the Health Care and Education Reconciliation Act) (P.L. 111-1148). (2010). United States, March 23, 2010.
    • (2010) Guidance for Sponsors: Information and Submission Requirements for Subsequent Entry Biologics (SEBs)
    • Health Canada1
  • 26
    • 84872418710 scopus 로고    scopus 로고
    • Impact of variability on the choice of biosimilarity limits in assessing followon biologics
    • Zhang, N., et al (2013). Impact of variability on the choice of biosimilarity limits in assessing followon biologics. Statistics in Medicine 32:424-433.
    • (2013) Statistics in Medicine , vol.32 , pp. 424-433
    • Zhang, N.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.