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Volumn 26, Issue 3, 2012, Pages 145-152

The US biosimilars act: Challenges facing regulatory approval

Author keywords

Bioequivalence; Biological products; Comparative pharmacokinetics; Food and Drug Administration; Guideline utilisation; Legislation; Product approvals; Regulatory process

Indexed keywords

BIOSIMILAR AGENT; ENOXAPARIN; RECOMBINANT ERYTHROPOIETIN; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR;

EID: 84860777212     PISSN: 11782595     EISSN: 11791993     Source Type: Journal    
DOI: 10.1007/bf03262388     Document Type: Review
Times cited : (28)

References (18)
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  • 10
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    • CHMP draft guideline. Similar biological medicinal products containing monoclonal antibodies. EMA/CHMP/BMWP/403543/2010 [online]. Available from URL: http://www.ema.europa.eu/docs/en-GB/document-library/ Scientific-guideline/2010/ 11/WC500099361.pdf [Accessed 2010 Nov 18]
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* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.