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Volumn 3, Issue 4, 2014, Pages 166-167

Biosimilars versus ‘biobetters’—a regulator’s perspective

Author keywords

Biobetter; Biosimilar; Competition; Interchangeability; Regulatory pathway

Indexed keywords


EID: 85008256560     PISSN: 20336403     EISSN: 20336772     Source Type: Journal    
DOI: 10.5639/gabij.2014.0304.039     Document Type: Note
Times cited : (20)

References (6)
  • 1
    • 85032497502 scopus 로고    scopus 로고
    • Rickwood S, Biase SD. Searching for terra firma in the biosimilars and non-original biologics market. IMS Health, 2013.
  • 2
    • 85032470737 scopus 로고    scopus 로고
    • DePalma A. Will biobetters beat biologics? October 2011 [homepage on the Internet]. [cited 2014 Nov 10]. Available from: http://social.eyeforpharma.com/forecasting/will-biobetters-beat-biologics
  • 4
    • 85032493496 scopus 로고    scopus 로고
    • European Medicines Agency. Questions and answers on biosimilar medicines (similar biological medicinal products). EMA/837805/2011. 27 September 2012 [homepage on the Internet]. [cited 2014 Nov 10]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Medicine_QA/2009/12/WC500020062.pdf
  • 5
    • 84911401436 scopus 로고    scopus 로고
    • Weise M, Kurki P, Wolff-Holz E, Bielsky MC, Schneider CK. Biosimilars: the science of extrapolation. Blood. 2014 Oct 8. pii: blood-2014-06-583617. [Epub ahead of print]
  • 6
    • 85032462101 scopus 로고    scopus 로고
    • European Medicines Agency. Draft guideline on similar biological medicinal products. CHMP/437/04 Rev 1. 22 May 2013 [homepage on the Internet]. [cited 2014 Nov 10]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/05/WC500142978.pdf


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.