Biologics Price Competition and Innovation Act of 2009
GPTKB entity
Statements (18)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:United_States_federal_law
|
| gptkbp:administeredBy |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:alsoKnownAs |
BPCI Act
|
| gptkbp:amendedBy |
gptkb:Public_Health_Service_Act
|
| gptkbp:citation |
Public Law 111-148, Title VII, Subtitle A, Sections 7001-7003
|
| gptkbp:dateEnacted |
March 23, 2010
|
| gptkbp:enables |
approval of biosimilars
|
| gptkbp:enactedBy |
gptkb:United_States_Congress
|
| https://www.w3.org/2000/01/rdf-schema#label |
Biologics Price Competition and Innovation Act of 2009
|
| gptkbp:partOf |
gptkb:Patient_Protection_and_Affordable_Care_Act
|
| gptkbp:provides |
12 years of exclusivity for reference biologics
|
| gptkbp:purpose |
create an abbreviated approval pathway for biosimilar and interchangeable biological products
|
| gptkbp:regulates |
biological products
|
| gptkbp:relatedTo |
gptkb:Affordable_Care_Act
|
| gptkbp:shortName |
BPCI Act
|
| gptkbp:signedBy |
gptkb:Barack_Obama
|
| gptkbp:bfsParent |
gptkb:Section_351:_Regulation_of_Biological_Products
|
| gptkbp:bfsLayer |
7
|