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Volumn 24, Issue 6, 2010, Pages 347-357

Physicochemical and biologic comparability of a biosimilar granulocyte colony-stimulating factor with its reference product

Author keywords

Biological products; Filgrastim; General

Indexed keywords

RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; UNCLASSIFIED DRUG; ZARZIO;

EID: 78049515273     PISSN: 11738804     EISSN: 1179190X     Source Type: Journal    
DOI: 10.2165/11585100-000000000-00000     Document Type: Article
Times cited : (71)

References (11)
  • 1
    • 69849092152 scopus 로고    scopus 로고
    • Economics of biological therapies
    • Kelly C, Mir F. Economics of biological therapies. BMJ 2009; 339: b3276
    • (2009) BMJ , vol.339
    • Kelly, C.1    Mir, F.2
  • 2
    • 33746169811 scopus 로고    scopus 로고
    • Biosimilars: How similar or dissimilar are they?
    • Roger SD. Biosimilars: how similar or dissimilar are they? Nephrology 2006; 11: 341-6
    • (2006) Nephrology , vol.11 , pp. 341-6
    • Roger, S.D.1
  • 3
    • 69449095403 scopus 로고    scopus 로고
    • Biosimilar therapeutics: What do we need to consider?
    • Schellekens H. Biosimilar therapeutics: what do we need to consider? NDT Plus 2009; 2 Suppl. 1: i27-36
    • (2009) NDT Plus , vol.2 , Issue.SUPPL. 1
    • Schellekens, H.1
  • 4
    • 33644952525 scopus 로고    scopus 로고
    • Committee for Medicinal Products for Human Use (CHMP), European Medicines Agency London: European Medicines Agency 2005 Oct 30 [online]. Available from URL [Accessed 2009 Oct 8]
    • Committee for Medicinal Products for Human Use (CHMP), European Medicines Agency. Guideline on similar biological medicinal products [CHMP/437/04]. London: European Medicines Agency 2005 Oct 30 [online]. Available from URL: http://www.emea.europa.eu/pdfs/human/biosimilar/043704en. pdf [Accessed 2009 Oct 8]
    • Guideline on Similar Biological Medicinal Products [CHMP/437/04]
  • 6
    • 84884281813 scopus 로고    scopus 로고
    • Annex to guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: Non-clinical and clinical issues
    • Committee for Medicinal Products for Human Use (CHMP), European Medicines Agency London: European Medicines Agency, 2006 Feb 22 [online]. Available from URL [Accessed 2009 Oct 8]
    • Committee for Medicinal Products for Human Use (CHMP), European Medicines Agency. Annex to guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. Guidance on similar medicinal products containing recombinant granulocyte-colony stimulating factor [EMEA/CHMP/BMWP/31329/2005]. London: European Medicines Agency, 2006 Feb 22 [online]. Available from URL: http://www.emea.europa.eu/pdfs/human/biosimilar/3132905en.pdf [Accessed 2009 Oct 8]
    • Guidance on Similar Medicinal Products Containing Recombinant Granulocyte-colony Stimulating Factor [EMEA/CHMP/BMWP/31329/2005]
  • 7
    • 8344224534 scopus 로고    scopus 로고
    • Characterizing biological products and assessing comparability following manufacturing changes
    • Chirino AJ, Mire-Sluis A. Characterizing biological products and assessing comparability following manufacturing changes. Nat Biotechnol 2004; 22: 1383-91
    • (2004) Nat Biotechnol , vol.22 , pp. 1383-91
    • Chirino, A.J.1    Mire-Sluis, A.2
  • 8
    • 70049109465 scopus 로고    scopus 로고
    • Binocrit: Assessment of quality, safety and efficacy of biopharmaceuticals
    • Brockmeyer C, Seidl A. Binocrit: assessment of quality, safety and efficacy of biopharmaceuticals. EJHP Practice 2009; 15: 34-40
    • (2009) EJHP Practice , vol.15 , pp. 34-40
    • Brockmeyer, C.1    Seidl, A.2
  • 9
    • 78049511773 scopus 로고    scopus 로고
    • Filgrastim concentrated solution [monograph no. 07/2010:2206] Strasbourg: European Directorate for the Quality of Medicines & HealthCare (EDQM)
    • Filgrastim concentrated solution [monograph no. 07/2010:2206]. In: European Pharmacopoeia. 6th ed. Suppl. 6.8. Strasbourg: European Directorate for the Quality of Medicines & HealthCare (EDQM), 2010
    • (2010) European Pharmacopoeia. 6th Ed Suppl. 6.8
  • 10
    • 35748959960 scopus 로고    scopus 로고
    • Pure red-cell aplasia "epidemic": Mystery completely revealed?
    • Locatelli F, Del Vecchio L, Pozzoni P. Pure red-cell aplasia "epidemic": mystery completely revealed? Perit Dial Int 2007; 27 Suppl. 2: S303-7
    • (2007) Perit Dial Int , vol.27 , Issue.SUPPL. 2
    • Locatelli, F.1    Del Vecchio, L.2    Pozzoni, P.3
  • 11
    • 77954262673 scopus 로고    scopus 로고
    • Development of anew G-CSF product based on biosimilarity assessment
    • Jul
    • GasconP,Fuhr U,Sorgel F, etal. Development of anew G-CSF product based on biosimilarity assessment. Ann Oncol 2010 Jul; 21 (7): 1419-29
    • (2010) Ann Oncol , vol.21 , Issue.7 , pp. 1419-29
    • Gascon, P.1    Fuhr, U.2    Sorgel, F.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.