PubMed · 2019 · 37 citations · 28 references
Open access
PharmacyHealth LawPharmacoeconomicsBioethicsRegulatory EconomicsRegulatory ScienceBiosafety RegulationBiosimilar RegulationDrug Acquisition CostsMarket Authorization ProceduresPharmacoeconomic EvaluationRegulatory Documentation For BioequivalenceBiosimilar MarketingBiosimilar SubstitutionGeneric Substitution In BiosimilarsMarket Access For BiosimilarsRegulatory Frameworks For Biosimilars
Evaluating biosimilars requires payers to go beyond cost considerations: safety and efficacy, reliability of supply and logistics, and the impact of state laws on substitution and interchangeability must all be deliberated.
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Pure Red-Cell Aplasia and Epoetin Therapy
Charles L. Bennett, Stefano Luminari, Allen R. Nissenson et al. · New England Journal of Medicine · 2004 · 432 citations · Full text
Key drivers for market penetration of biosimilars in Europe
C. Rémuzat, J Dorey, Olivier Cristeau et al. · Journal of Market Access & Health Policy · 2017 · 213 citations · Full text
Developing the Nation's Biosimilars Program
Steven Kozlowski, Janet Woodcock, Karen Midthun et al. · New England Journal of Medicine · 2011 · 196 citations
Pharmacy, Pharmaceutical Policy, Drug Approval Processes +15