Market exclusivity for biologics [7]

New England Journal of Medicine

Volumn 362, Issue 7, 2010, Pages 661-662

  Wheadon, David E ^a  

^a Pharmaceutical Research and Manufacturers of America   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL PRODUCT;

DRUG APPROVAL; DRUG MARKETING; FOOD AND DRUG ADMINISTRATION; LETTER; PRIORITY JOURNAL; DRUG INDUSTRY; ECONOMICS; LEGAL ASPECT; MARKETING; NOTE; PATENT; UNITED STATES;

BIOLOGICAL PRODUCTS; DRUG APPROVAL; DRUG INDUSTRY; MARKETING; PATENTS AS TOPIC; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 77149148170     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMc0912463     Document Type: Letter

References (4)

1. Engelberg AB, Kesselheim AS, Avorn J. Balancing innovation, access, and profits - market exclusivity for biologics. N Engl J Med 2009;361:1917-9.
2. Grabowski H, Cockburn I, Long G. The market for follow-on biologics: how will it evolve? Health Aff (Millwood) 2006;25:1291-301.
3. Cockburn I, Lerner J. The cost of capital for early-stage biotechnology ventures. In: Pisano G. Science business: the promise, the reality and the future of biotech. Cambridge, MA: Harvard Business School Press, 2006:115.
4. Avoiding no man's land: potential unintended consequences of follow-on biologics. Deloitte white paper, March 2009. (Accessed January 28, 2010, at http://www.pharmamanufacturing.com/Media/1001/Deloitte-Biosimilars.pdf.)