Biosimilars in Europe /

Biosimilars in Europe / / Arnold G Vulto, Steven Simoens, Isabelle Huys, editors.

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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Bibliographic Details
TeilnehmendeR:
Huys, Isabelle,
Simoens, Steven,
Vulto, Arnold G,
Place / Publishing House:[Place of publication not identified] : : MDPI - Multidisciplinary Digital Publishing Institute,, 2023.
Year of Publication:2023
Language:English
Physical Description:1 online resource (188 pages)
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Table of Contents:
  • 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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