# OnCo record idea-reg-biosimilar-no-efficacy-trial (idea). 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/ideas/idea-reg-biosimilar-no-efficacy-trial/>
  a schema:CreativeWork ;
  onco:kind "idea" ;
  schema:identifier "idea-reg-biosimilar-no-efficacy-trial" ;
  schema:name "Approve cancer biosimilars on analytics and pharmacokinetics, no efficacy trials"@en ;
  schema:description "Copies of biological cancer drugs are still required to run large trials that rarely change the answer. Dropping them would cut years and tens of millions from each biosimilar."@en ;
  schema:url <https://onco.cc/ideas/idea-reg-biosimilar-no-efficacy-trial/> ;
  schema:dateModified "2026-09-08"^^xsd:date ;
  schema:citation <https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-guidelines/multidisciplinary-guidelines/multidisciplinary-biosimilar> ;
  onco:technologies <https://onco.cc/technologies/monoclonal-antibody/> ;
  onco:drugs <https://onco.cc/drugs/trastuzumab/>, <https://onco.cc/drugs/pembrolizumab/>, <https://onco.cc/drugs/nivolumab/> ;
  onco:bottlenecks <https://onco.cc/bottlenecks/b-drug-pricing/>, <https://onco.cc/bottlenecks/b-regulatory-fragmentation/> .