Biogenerics: the hope and the hype

Trends in Biotechnology

Volumn 27, Issue 8, 2009, Pages 443-444

  Miller, Henry I ^a  

^a STANFORD UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BEVACIZUMAB; ETANERCEPT; GENERIC DRUG; HUMAN GROWTH HORMONE; HYALURONIDASE; HYLENEX; LUMIZYME; RECOMBINANT ERYTHROPOIETIN; RECOMBINANT GLUCAGON; RECOMBINANT GLUCAN 1,4 ALPHA GLUCOSIDASE; SALCATONIN; UNCLASSIFIED DRUG; WART VIRUS VACCINE;

ARTICLE; BIOSAFETY; BIOTECHNOLOGY; DRUG COST; DRUG DOSAGE FORM COMPARISON; DRUG IMPURITY; DRUG INDUSTRY; DRUG MANUFACTURE; DRUG MARKETING; DRUG RESEARCH; FOOD AND DRUG ADMINISTRATION; GOVERNMENT REGULATION; HEALTH CARE COST; HUMAN; MEDICAID; MEDICARE; PRIORITY JOURNAL; PURE RED CELL ANEMIA;

EID: 67650692717     PISSN: 01677799     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.tibtech.2009.04.005     Document Type: Note

References (5)

1. Anonymous (2009) Senators Announce Bipartisan Proposal To Bring Generic Biologic Drugs To Market, Saving Billions In Medicare Costs [Press release, 26 March 2009] (http://vitter.senate.gov/public/index.cfm?FuseAction=PressRoom.PressReleases&ContentRecord_id=482f3d72-a00d-ec7a-e599-a874f852c445&Region_id=&Issue_id=1440e2b6-2a4f-433e-b31a-58a675aa6790, accessed April 2, 2009)
2. Editorial (2008) Merck to Develop Biotech Generics, The Wall Street Journal 10 December, p. B1 (http://online.wsj.com/article/SB122883224274591361.html?mod=wsjcrmain, accessed April 2, 2009)
3. Bennett C.L., et al. Pure red-cell aplasia and epoetin therapy. N. Engl. J. Med. 351 (2004) 1403-1408
4. Woodcock, J. (2007) Follow-on Protein Products: Statement of Janet Woodcock, M.D. Deputy Commissioner, Chief Medical Officer, Food and Drug Administration, before The Committee on Oversight and Government Reform United States House of Representatives, March 26, 2007 (http://www.fda.gov/NewsEvents/Testimony/ucm154070.htm, accessed June 15, 2009)
5. Pierson, R. (2009) Genzyme's Lumizyme faces delay after FDA rejection, Reuters 2 March (http://www.reuters.com/article/healthNews/idUSTRE5216V020090302, accessed April 3, 2009)