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Statements

Subject Item
dbr:2016_term_United_States_Supreme_Court_opinions_of_Clarence_Thomas
dbo:wikiPageWikiLink
dbr:Biologics_Price_Competition_and_Innovation_Act_of_2009
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dbr:2016_term_United_States_Supreme_Court_opinions_of_Stephen_Breyer
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dbr:Biologics_Price_Competition_and_Innovation_Act_of_2009
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dbr:Filgrastim
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dbr:Biologics_Price_Competition_and_Innovation_Act_of_2009
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dbr:Biologics_Price_Competition_and_Innovation_Act_of_2009_(BPCI_Act)
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dbr:Biologics_Price_Competition_and_Innovation_Act_of_2009
Subject Item
dbr:Biologics_Price_Competition_and_Innovation_Act_of_2009
rdfs:label
Biologics Price Competition and Innovation Act of 2009
rdfs:comment
The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) amends the Public Health Service Act (PHS Act) to create an abbreviated approval pathway for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed reference biological product. The BPCI Act is closely related to the Drug Price Competition and Patent Term Restoration Act of 1984 (or referred to as the "Hatch-Waxman Act"), which established abbreviated pathways for the approval of drug products under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
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dbc:Patent_law dbc:United_States_federal_patent_legislation dbc:United_States_Public_Health_Service dbc:Biotechnology_law dbc:United_States_federal_health_legislation
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29218677
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1111059696
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The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) amends the Public Health Service Act (PHS Act) to create an abbreviated approval pathway for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed reference biological product. The BPCI Act is closely related to the Drug Price Competition and Patent Term Restoration Act of 1984 (or referred to as the "Hatch-Waxman Act"), which established abbreviated pathways for the approval of drug products under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
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wikipedia-en:Biologics_Price_Competition_and_Innovation_Act_of_2009?oldid=1111059696&ns=0
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wikipedia-en:Biologics_Price_Competition_and_Innovation_Act_of_2009
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dbr:Biosimilar
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wikipedia-en:Biologics_Price_Competition_and_Innovation_Act_of_2009
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