Why an abbreviated FDA pathway for biosimilars is overhyped

Nature Biotechnology

Volumn 29, Issue 9, 2011, Pages 794-795

  Miller, Henry I ^a  

^a STANFORD UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

GENERIC DRUG; NEW DRUG;

BIOTECHNOLOGY; COMPETITION; COST CONTROL; DRUG INDUSTRY; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; GOVERNMENT; HEALTH CARE COST; HEALTH INSURANCE; HUMAN; LETTER; NONHUMAN; POLICY; PRIORITY JOURNAL; SCIENCE; UNITED STATES;

BIOLOGICAL AGENTS; BIOPHARMACEUTICS; BIOTECHNOLOGY; DRUGS, GENERIC; THERAPEUTIC EQUIVALENCY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 80052781687     PISSN: 10870156     EISSN: 15461696     Source Type: Journal    
DOI: 10.1038/nbt.1960     Document Type: Letter

References (3)

1. Department of Health and Human Services. Fed. Regist. 75, 61497-61501 (2010). http://edocket. access.gpo.gov/2010/pdf/2010-24853.pdf
2. Kozlowski, S. et al. N. Eng. J. Med. 365, 385-388 (2011).
3. Woodcock, J. et al. Nat. Rev. Drug Discov. 6, 437-442 (2007).