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Volumn 25, Issue 1, 2011, Pages 63-67
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US biosimilar pathway unlikely to be used
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Author keywords
Biological products; Generic drugs; Legislation; Regulatory process
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Indexed keywords
ALENDRONIC ACID;
BETA1A INTERFERON;
BEVACIZUMAB;
BIOLOGICAL PRODUCT;
CETUXIMAB;
GLATIRAMER;
HUMAN GROWTH HORMONE;
INTERFERON BETA SERINE;
MK 2578;
NEUTROVAL;
NOVEL ERYTHROPOIESIS STIMULATING PROTEIN;
RECOMBINANT ERYTHROPOIETIN;
RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR;
RITUXIMAB;
TRASTUZUMAB;
UNCLASSIFIED DRUG;
ANEMIA;
ARTICLE;
AUSTRALIA;
BIOPROCESS;
CANADA;
DRUG APPROVAL;
DRUG COST;
DRUG INDUSTRY;
DRUG LEGISLATION;
DRUG MANUFACTURE;
DRUG MARKETING;
EUROPE;
FOOD AND DRUG ADMINISTRATION;
HEALTH CARE POLICY;
HUMAN;
JAPAN;
KIDNEY DYSFUNCTION;
LICENSING;
PATENT;
PHASE 1 CLINICAL TRIAL (TOPIC);
PRIORITY JOURNAL;
UNITED STATES;
WORLD HEALTH ORGANIZATION;
ANIMALS;
BIOLOGICAL PRODUCTS;
DRUGS, GENERIC;
ECONOMIC COMPETITION;
HEALTH CARE REFORM;
HUMANS;
LICENSURE;
THERAPEUTIC EQUIVALENCY;
UNITED STATES;
UNITED STATES FOOD AND DRUG ADMINISTRATION;
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EID: 78651372527
PISSN: 11738804
EISSN: 1179190X
Source Type: Journal
DOI: 10.2165/11588410-000000000-00000 Document Type: Article |
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Times cited : (12)
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References (5)
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