A qualitative study of biosimilar manufacturer and regulator perceptions on intellectual property and abbreviated approval pathways
Louise C. Druedahl, Anna Birna Almarsdóttir, Sofia Kälvemark Sporrong, Marie L. De Bruin, Hans Hoogland, Timo Minssen, Marco van de Weert, Aaron S. Kesselheim, Ameet Sarpatwari
Topics & Concepts
BiosimilarIntellectual propertyBusinessCompetition (biology)Drug approvalRegulatorPublic economicsMarketingAccountingIndustrial organizationPharmacologyDrugEconomicsMedicinePolitical scienceLawInternal medicineChemistryGeneBiochemistryEcologyBiologyBiosimilars and Bioanalytical MethodsPharmaceutical Economics and PolicyBiomedical Ethics and Regulation