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

• 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)

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.

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.