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Volumn 13, Issue 7, 2017, Pages 391-392

Pharmacotherapy: Biosimilar switching-"To set a form upon desired change"

Author keywords

[No Author keywords available]

Indexed keywords

BIOSIMILAR AGENT; DRUG ANTIBODY; ETANERCEPT; ETANERCEPT SZZS; INFLIXIMAB; INFLIXIMAB DYYB; CT-P13; MONOCLONAL ANTIBODY;

EID: 85020958466     PISSN: 17594790     EISSN: 17594804     Source Type: Journal    
DOI: 10.1038/nrrheum.2017.79     Document Type: Short Survey
Times cited : (8)

References (10)
  • 1
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    • Switching from originator infliximab to biosimilar CT-P13 compared to maintained treatment with originator infliximab (NOR-SWITCH): A 52-week randomised double-blind non-inferiority trial
    • Jørgensen, K. K. et al. Switching from originator infliximab to biosimilar CT-P13 compared to maintained treatment with originator infliximab (NOR-SWITCH): a 52-week randomised double-blind non-inferiority trial. Lancet http://dx.doi.org/10.1016/ S0140-6736(17)30068-5 (2017).
    • (2017) Lancet
    • Jørgensen, K.K.1
  • 2
    • 84883752718 scopus 로고    scopus 로고
    • A randomised, double-blind, parallelgroup study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: The PLANETRA study
    • Yoo, D. H. et al. A randomised, double-blind, parallelgroup study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study. Ann. Rheum. Dis. 72, 1613-1620 (2013).
    • (2013) Ann. Rheum. Dis. , vol.72 , pp. 1613-1620
    • Yoo, D.H.1
  • 3
    • 84984596871 scopus 로고    scopus 로고
    • Clinical trials of biosimilars should become more similar
    • Kay, J. & Isaacs, J. D. Clinical trials of biosimilars should become more similar. Ann. Rheum. Dis. 76, 4-6 (2017).
    • (2017) Ann. Rheum. Dis. , vol.76 , pp. 4-6
    • Kay, J.1    Isaacs, J.D.2
  • 5
    • 85014009195 scopus 로고    scopus 로고
    • The EGALITY study: A confirmatory, randomised, double-blind study comparing the efficacy, safety and immunogenicity of GP2015, a proposed etanercept biosimilar, versus the originator product in patients with moderate to severe chronic plaque-type psoriasis
    • Griffiths, C. E. et al. The EGALITY study: a confirmatory, randomised, double-blind study comparing the efficacy, safety and immunogenicity of GP2015, a proposed etanercept biosimilar, versus the originator product in patients with moderate to severe chronic plaque-type psoriasis. Br. J. Dermatol. 176, 928-938 (2017).
    • (2017) Br. J. Dermatol. , vol.176 , pp. 928-938
    • Griffiths, C.E.1
  • 6
    • 85021021919 scopus 로고    scopus 로고
    • Biologics Price Competition and Innovation Act of 2009, 119 United States Code, 7001-7003
    • Biologics Price Competition and Innovation Act of 2009, 119 United States Code, 7001-7003. https:// www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/ UCM216146.pdf (2010).
    • (2010)
  • 7
    • 85008253096 scopus 로고    scopus 로고
    • Subsequent entry biologics (biosimilars) in Canada: Approaches to interchangeability and the extrapolation of indications and uses
    • Klein, A. V., Wang, J. & Bedford, P. Subsequent entry biologics (biosimilars) in Canada: approaches to interchangeability and the extrapolation of indications and uses. GaBI J. 3, 150-154 (2014).
    • (2014) GaBI J. , vol.3 , pp. 150-154
    • Klein, A.V.1    Wang, J.2    Bedford, P.3
  • 8
    • 85014204942 scopus 로고    scopus 로고
    • Legislations on biosimilar interchangeability in the US and EU-developments far from visibility
    • Thimmaraju, P. K., Rakshambikai, R., Farista, R. & Juluru, K. Legislations on biosimilar interchangeability in the US and EU-developments far from visibility. GaBI Online http://www.gabionline.net/Sponsored-Articles/Legislations-on-biosimilar-interchangeabilityin-the-US-and-EU-developments-far-from-visibility (2015).
    • (2015) GaBI Online
    • Thimmaraju, P.K.1    Rakshambikai, R.2    Farista, R.3    Juluru, K.4
  • 9
    • 85020955263 scopus 로고    scopus 로고
    • GaBI Online-Generics and Biosimilars Initiative. France to allow biosimilars substitution
    • GaBI Online-Generics and Biosimilars Initiative. France to allow biosimilars substitution. GaBI Online http://www.gabionline.net/Policies-Legislation/Franceto-allow-biosimilars-substitution (2014).
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  • 10
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    • Lunddahl, B. Pharmacovigilance on biologicals and biosimilars: a Danish perspective. GaBI J. 5, 123-124 (2016).
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* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.