5Avidor Y, Mabjeesh NJ,Matzkirl H.Bioteehnology and drug discovery: from bench to bedside[J].South Med J,2003,96( 12): 1174-1186.
6European Parliament and Council.Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004[J].Off J Eur Union,2004,47:34-57.
7European Medicines Agency, Guideline on similar biological medicinal products 2005[EB/OL]. http://www.tga.gov.au/DOCS/ pdf/euguide/chrnp/043704final.pdf,2005-10-30/2008-03-04.
8US Food and Drug Administration.Omnitrope (somatropin [rDNA origin]) questions and answers 2006[EB/OL].http://www.fda.gov/ cder/drug/infopage/somatropin/qa.htm,2006-09-15/2008-03 -03.
9Crommelin DJ,Bermejo T, Bissig M,et al.Pharmaceutical evaluation of biosimilars: important differences from generic low-molecular weight pharm[J].Eur J Hosp Pharm Sci,2005,11(1):11-17.
10Roger SD.Biosimilars: how similar or dissimilar are they? [J]. Nephrology (Carlton),2006,11 (4):341-346.
