# OnCo record bpcia (term). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)". Whole corpus: https://onco.cc/api/v1/onco.nt
@prefix schema: <https://schema.org/> .
@prefix onco: <https://onco.cc/ns#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

<https://onco.cc/terms/bpcia/>
  a schema:DefinedTerm ;
  onco:kind "term" ;
  schema:identifier "bpcia" ;
  schema:name "Biologics Price Competition and Innovation Act 2010"@en ;
  schema:alternateName "BPCIA"@en, "biosimilar pathway"@en, "351(k)"@en, "351(k) pathway"@en, "abbreviated biologics licence application"@en, "twelve-year biologic exclusivity"@en, "12-year exclusivity"@en, "interchangeability"@en, "interchangeable biosimilar"@en, "patent dance"@en, "Purple Book"@en ;
  schema:description "The 2010 US law that created a route for copies of biologic drugs such as trastuzumab and rituximab, while giving the original twelve years of protection from those copies."@en ;
  schema:url <https://onco.cc/terms/bpcia/> ;
  schema:dateModified "2026-09-17"^^xsd:date ;
  schema:sameAs <https://en.wikipedia.org/wiki/Biologics_Price_Competition_and_Innovation_Act_of_2009> ;
  schema:citation <https://en.wikipedia.org/wiki/Biologics_Price_Competition_and_Innovation_Act_of_2009>, <https://www.fda.gov/drugs/therapeutic-biologics-applications-bla/biosimilars>, <https://www.fda.gov/drugs/development-approval-process-drugs/frequently-asked-questions-patents-and-exclusivity> ;
  onco:tag "law", "us" ;
  onco:related <https://onco.cc/terms/biosimilar/>, <https://onco.cc/terms/hatch-waxman/>, <https://onco.cc/terms/us-regulatory-exclusivity/>, <https://onco.cc/drugs/trastuzumab-biosimilars/>, <https://onco.cc/terms/inflation-reduction-act/>, <https://onco.cc/terms/eu-data-exclusivity/>, <https://onco.cc/terms/340b-program/> ;
  onco:drugs <https://onco.cc/drugs/trastuzumab/>, <https://onco.cc/drugs/rituximab/>, <https://onco.cc/drugs/bevacizumab/> ;
  onco:bottlenecks <https://onco.cc/bottlenecks/b-drug-pricing/> .