LEADER 02895nam 2200409 450 001 9910647225803321 005 20230324024158.0 010 $a3-0365-6574-4 035 $a(CKB)5680000000300089 035 $a(NjHacI)995680000000300089 035 $a(EXLCZ)995680000000300089 100 $a20230324d2023 uy 0 101 0 $aeng 135 $aur||||||||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 00$aBiosimilars in Europe /$fArnold G Vulto, Steven Simoens, Isabelle Huys, editors 210 1$a[Place of publication not identified] :$cMDPI - Multidisciplinary Digital Publishing Institute,$d2023. 215 $a1 online resource (188 pages) 311 $a3-0365-6575-2 327 $aAbout 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. 330 $aThis 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. 606 $aValue analysis (Cost control) 606 $acost containment 615 0$aValue analysis (Cost control) 615 0$acost containment. 676 $a658.1552 702 $aHuys$b Isabelle 702 $aSimoens$b Steven 702 $aVulto$b Arnold G 801 0$bNjHacI 801 1$bNjHacl 906 $aBOOK 912 $a9910647225803321 996 $aBiosimilars in Europe$93018148 997 $aUNINA