LEADER 05239nam 2200625 450 001 9910464060003321 005 20200520144314.0 010 $a3-95489-687-7 035 $a(CKB)2670000000534296 035 $a(EBL)1640288 035 $a(SSID)ssj0001216991 035 $a(PQKBManifestationID)11669600 035 $a(PQKBTitleCode)TC0001216991 035 $a(PQKBWorkID)11202059 035 $a(PQKB)11000918 035 $a(MiAaPQ)EBC1640288 035 $a(Au-PeEL)EBL1640288 035 $a(CaPaEBR)ebr10856569 035 $a(OCoLC)871779662 035 $a(EXLCZ)992670000000534296 100 $a20140416h20142014 uy 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 10$aRift-lines within European regulatory framework for biosimilars when taking heterogeneity and variation during lifecycle of the reference biologic and the biosimilar into account /$fMalik Osmane 210 1$aHamburg, Germany :$cAnchor Academic Publishing,$d2014. 210 4$dİ2014 215 $a1 online resource (283 p.) 300 $aDescription based upon print version of record. 311 $a3-95489-187-5 320 $aIncludes bibliographical references. 327 $aRift-lines within european regulatory framework for biosimilars when taking heterogeneity and variation during lifecycle of the reference biologic and the biosimilar into account; Abstract; Table of Contents; Acknowledgements; List of abbreviations; Chapter 1.0: Introduction; 1.0. Rationale on the selection of the topic (as guide for future students); 1.1 Definitions; 1.2 Statement of the main problem, subsequent research questions and test-functions; 1.3 Study "Within Scope" and "Out of Scope"; 1.4 Description of the European Regulatory Environment with Regard to Biosimilars 327 $a1.5. Why are biosimilars interesting for the generic industry?Chapter 2.0: Literature review; 2.1. Re-presenting the current biosimilar legislation and regulatory requirements; 2.2 Life cycle in relation to heterogeneity and variation; 2.3 Screening the above presented literature related to current biosimilar regulation withregard to the research questions; 2.4. Reference to other biosimilar regulations; 2.2 Teil 2:Life cycle in relation to heterogeneity and variation 327 $a2.3 Teil 2: Screening the above presented literature related to current biosimilar regulation with regard to the research questions2.4. Teil 2:Reference to other biosimilar regulations (for informationalpurposes only); Chapter 3.0: Materials and Methods; 3.1 Methods used and rational for choosing them; 3.2 Rationale for using the employed research methodologies; 3.3 Practical aspects; Chapter 4.0: What are the implications of heterogeneity and variation through the life cycle of the biosimilar and the reference biologic, from a European perspective?; 4.1 Introduction 327 $a4.2 Experimental procedure (methods and materials) employed4.3 Results for main research questions 1.0 and directly associated research questions 1.1 and 1.2 that discuss the impact of the dynamic to the quality profile; 4.4 Discussion; Chapter 5.0: What should be the scope of trials?; 5.1 Introduction; 5.2 Experimental procedure (methods and materials) employed; 5.3 Results for the series 2 research questions; 5.4 Discussion; Chapter 6.0: Why is extrapolation of indications for biosimilar controversial?; 6.1 Introduction; 6.2 Experimental procedure (methods and materials) employed 327 $a6.3 Results from why is extrapolation of indications for biosimilar controversial?6.4 Discussion; Chapter 7.0 Integrated discussion; 7.1 Part I: General Comments; 7.2 Part II: Findings evaluation; 7.3 Part III: Discussion of solutions (and outlook); Chapter 8.0 Integrated conclusion; Bibliography or References; List of Appendices; Appendix: 1; Appendix: 2; Appendix: 3; Appendix: 4; Appendix: 5 330 $aBiopharmaceutical medicinal products (biologics) represent a huge financial market. Thus upon patent protection expiry of the innovator (reference) biologic there is interest from industry to gain a portion of this market by launching a 'similar' biologic at a reduced development cost, thus boosting potential gains. The EMA responded to this desire and lead the guidance process with industry on the topic of biosimilars. Based on the experience gained with biosimilars in the past, the EMA started to introduce a second generation series of guidance documents, which take into account the past, cu 606 $aBiological products 606 $aDrugs$xGeneric substitution 606 $aPharmaceutical biotechnology industry 608 $aElectronic books. 615 0$aBiological products. 615 0$aDrugs$xGeneric substitution. 615 0$aPharmaceutical biotechnology industry. 676 $a572 700 $aOsmane$b Malik$0970126 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910464060003321 996 $aRift-lines within European regulatory framework for biosimilars when taking heterogeneity and variation during lifecycle of the reference biologic and the biosimilar into account$92205102 997 $aUNINA