The Oncologist · 2018 · 28 citations · 16 references
PharmacyOncologyPharmaceutical PolicyDrug Approval ProcessesMedical OncologyPharmaceutical RegulationAccess To MedicinesBiologic TherapeuticsBiosimilar RegulationDrug ApprovalNew Drug ApplicationsOncology PharmacologyAccess To BiosimilarsBiosimilar EntryBiosimilar MarketingBiosimilar PharmacokineticsGuideline Development For BiosimilarsMarket Access For BiosimilarsQuality Standards For BiosimilarsRegulatory Frameworks For Biosimilars
Biosimilars are biological compounds that contain an active substance that is similar to the active substance in an already approved biologic. This commentary focuses on the barriers to the use of biosimilars in the United States.
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Biosimilars: the science of extrapolation
Martina Weise, Pekka Kurki, Elena Wolff‐Holz et al. · Blood · 2014 · 295 citations · Full text
Obstacles to the Adoption of Biosimilars for Chronic Diseases
Aaron Hakim, Joseph S. Ross · JAMA · 2017 · 74 citations