Competition in the age of biosimilars

JAMA - Journal of the American Medical Association

Volumn 314, Issue 3, 2015, Pages 225-226

  Chandra, Amitabh ^a   Vanderpuye Orgle, Jacqueline ^b  

^a HARVARD UNIVERSITY   (United States)

^b PRECISION HEALTH ECONOMICS   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BIOSIMILAR AGENT; FILGRASTIM; INFLIXIMAB; PEGFILGRASTIM; RECOMBINANT ERYTHROPOIETIN;

AUSTRALIA; BIOEQUIVALENCE; COST CONTROL; DRUG APPROVAL; DRUG INDICATION; DRUG INDUSTRY; DRUG LABELING; DRUG MANUFACTURE; DRUG MARKETING; DRUG PACKAGING; DRUG POTENCY; DRUG SAFETY; DRUG USE; FOOD AND DRUG ADMINISTRATION; HEALTH CARE POLICY; HUMAN; JAPAN; PATENT; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; REIMBURSEMENT; SHORT SURVEY; UNITED STATES; UNSPECIFIED SIDE EFFECT; DRUG SURVEILLANCE PROGRAM; ECONOMIC ASPECT; ECONOMICS; NOMENCLATURE; STANDARDS; THERAPEUTIC EQUIVALENCE;

ADVERSE DRUG REACTION REPORTING SYSTEMS; BIOSIMILAR PHARMACEUTICALS; DRUG APPROVAL; DRUG INDUSTRY; DRUG LABELING; ECONOMIC COMPETITION; NAMES; THERAPEUTIC EQUIVALENCY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84938321230     PISSN: 00987484     EISSN: 15383598     Source Type: Journal    
DOI: 10.1001/jama.2015.6170     Document Type: Short Survey

References (7)

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2. Biologics Price Competition and Innovation Act of 2009, Pub L No. 111-148, 124 Stat 119.
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6. US Food and Drug Administration. FDA approves first biosimilar product Zarxio. March 6, 2015. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm436648.htm. Accessed June 16, 2015.
7. Database of Adverse Event Notifications-Medicines. Symonston, Australia: Therapeutic Goods Administration; 2015.