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Record Nr. |
UNINA9910647225803321 |
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Titolo |
Biosimilars in Europe / / Arnold G Vulto, Steven Simoens, Isabelle Huys, editors |
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Pubbl/distr/stampa |
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[Place of publication not identified] : , : MDPI - Multidisciplinary Digital Publishing Institute, , 2023 |
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ISBN |
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Descrizione fisica |
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1 online resource (188 pages) |
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Disciplina |
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Soggetti |
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Value analysis (Cost control) |
cost containment |
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Lingua di pubblicazione |
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Formato |
Materiale a stampa |
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Livello bibliografico |
Monografia |
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Nota di contenuto |
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About the Editors vii -- Emerging Insights into European Markets of Biologics, Including Biosimilars 1 -- Budget Impact Analysis of Biosimilar Products in Spain in the Period 2009-2019 5 -- Did the Introduction of Biosimilars Influence Their Prices and Utilization? The Case of Biologic Disease Modifying Antirheumatic Drugs (bDMARD) in Bulgaria 21 -- Simulating Costs of Intravenous Biosimilar Trastuzumab vs. Subcutaneous Reference Trastuzumab in Adjuvant HER2-Positive Breast Cancer: A Belgian Case Study 31 -- Learnings from Regional Market Dynamics of Originator and Biosimilar Infliximab and Etanercept in Germany 39 -- Barriers to Biosimilar Prescribing Incentives in the Context of Clinical Governance in Spain 59 -- The Off-Patent Biological Market in Belgium: Is the Health System Creating a Hurdle to Fair Market Competition? 75 -- Off-Patent Biologicals and Biosimilars Tendering in Europe-A Proposal towards More Sustainable Practices 81 -- Sustainability of Biosimilars in Europe: A Delphi Panel Consensus with Systematic Literature Review 109 -- Analysis of the Regulatory Science Applied to a Single Portfolio of Eight Biosimilar Product Approvals by Four Key Regulatory Authorities 127 -- Type and Extent of Information on (Potentially Critical) Quality Attributes Described in European Public Assessment Reports for Adalimumab Biosimilars 143 -- Informing Patients about Biosimilar Medicines: The Role of European Patient Associations 157. |
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Sommario/riassunto |
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This reprint examines regulatory, pricing and reimbursement issues related to the market access and uptake of off-patent biologics, biosimilars, next-generation biologics and competing innovative medicines in European countries. |
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