Assessing the safety and comparative effectiveness of follow-on biologics (biosimilars) in the United States

Clinical Pharmacology and Therapeutics

Volumn 87, Issue 2, 2010, Pages 157-159

  Hennessy, S ^a   Leonard, C E ^a   Platt, R ^b  

^a UNIVERSITY OF PENNSYLVANIA   (United States)

^b HARVARD MEDICAL SCHOOL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL PRODUCT; NATALIZUMAB;

DRUG SAFETY; ELECTRONIC MEDICAL RECORD; FOOD AND DRUG ADMINISTRATION; NOTE; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; RISK ASSESSMENT; UNITED STATES;

BIOLOGICAL PRODUCTS; COMPARATIVE EFFECTIVENESS RESEARCH; DRUG APPROVAL; DRUGS, GENERIC; HUMANS; LEGISLATION, DRUG; PRODUCT SURVEILLANCE, POSTMARKETING; THERAPEUTIC EQUIVALENCY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 75749134951     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1038/clpt.2009.249     Document Type: Note

References (6)

1. Woodcock, J. et al. The FDA's assessment of follow-on protein products: a historical perspective. Nat. Rev. Drug Discov. 6, 437-442 (2007).
2. Medicare Payment Advisory Commission. Report to the Congress: Improving Incentives in the Medicare Program (MedPAC, Washington, DC, 2009).
3. Macdougall, I.C. Pure red cell aplasia with anti-erythropoietin antibodies occurs more commonly with one formulation of epoetin alfa than another. Curr. Med. Res. Opin. 20, 83-86 (2004).
4. 110th Congress. Food and Drug Administration Amendments Act of 2007. Public Law 110-185, 27 July 2007.
5. 111th Congress. American Recovery and Reinvestment Act of 2009. Public Law 111-115, 6 January 2009.
6. Douglas, P.S. et al. Clinical effectiveness of coronary stents in elderly persons: results from 262,700 Medicare patients in the American College of Cardiology-National Cardiovascular Data Registry. J. Am. Coll. Cardiol. 53, 1629-1641 (2009).