000 04356nam a22005175i 4500
001 978-2-8178-0336-4
003 DE-He213
005 20140220082835.0
007 cr nn 008mamaa
008 121120s2013 fr | s |||| 0|eng d
020 _a9782817803364
_9978-2-8178-0336-4
024 7 _a10.1007/978-2-8178-0336-4
_2doi
050 4 _aRC254-282
072 7 _aMJCL
_2bicssc
072 7 _aMED062000
_2bisacsh
082 0 4 _a616.994
_223
100 1 _aPrugnaud, Jean-Louis.
_eeditor.
245 1 0 _aBiosimilars
_h[electronic resource] :
_bA New Generation of Biologics /
_cedited by Jean-Louis Prugnaud, Jean-Hugues Trouvin.
264 1 _aParis :
_bSpringer Paris :
_bImprint: Springer,
_c2013.
300 _aXVII, 87 p. 7 illus., 5 illus. in color.
_bonline resource.
336 _atext
_btxt
_2rdacontent
337 _acomputer
_bc
_2rdamedia
338 _aonline resource
_bcr
_2rdacarrier
347 _atext file
_bPDF
_2rda
505 0 _aPreface: Biosimilars – a philosophy? -- Foreword -- 1. Biosimilars characteristics -- Introduction : from generics to biosimilars -- Definitions -- Complexity of biologics and examples -- Conclusion -- 2. From the biosimilar concept to the Marketing Approval. –Introduction -- Definition of biosimilars -- Pharmaceutical approval’s framework -- Quality control approach -- Non clinical and clinical aspects -- Recommendations in onco-hematology -- Other recommendations -- Conclusion -- 3. Immunogenicity -- Introduction -- Immune mechanisms -- Usual immune response -- Immunologic tolerance breakdown response -- Factors influencing immunogenicity -- Case of monoclonal antibodies -- Conclusion -- 4. Substitution and interchangeability -- Introduction -- Generics and biosimilars’ substitution -- What about biosimilar medicinal  products ? -- Interchangeability: suggested definition -- Biosimilars’ interchangeability and conditions to be implemented -- Interchangeability practices -- Conclusion -- 5. Onco-hematologist point of view –GCSFcase -- Biosimilars -- Conclusion -- 6. The oncologist‘s point of view -- Introduction -- Erythropoiesis-stimulating Agents (ESA) -- Biosimilars -- Conclusion -- 7. Challenges posed by biosimilars: who is responsible for cost and risk management -- Introduction -- General information on cost management -- Savings linked to the purchase of biosimilars -- General information on risk management responsibility -- Conclusion.
520 _aBiologics have revolutionised the treatment of many severe conditions, delivering exceptional clinical results but also producing exceptionally high prices. As patents expire, copies and price competition are expected throughout the world. However, due to the intrinsic heterogeneity and molecular complexity of biologic medicinal products, their copies cannot simply be authorized under the “generic rule” valid for small chemical entities.   In response, a dedicated regulation was issued in the European Union. It is based on the concept of “biological medicinal products similar to a biological reference product”, or “biosimilars”. This book analyses the context of biotechnological production and addresses the European legal framework for biosimilar market approval. It highlights post-market authorisation issues, such as Risk Management Plans and substitution of products, and outlines some other issues, such as cost management and international nomenclature.   This book is primarily intended for hospital-based physicians and pharmacists. It will also be a valuable resource for all actors from all countries who want to better understand the emergence of these new medicinal products within the European context.
650 0 _aMedicine.
650 0 _aImmunology.
650 0 _aPharmaceutical technology.
650 0 _aPharmacy.
650 0 _aNephrology.
650 0 _aOncology.
650 1 4 _aMedicine & Public Health.
650 2 4 _aOncology.
650 2 4 _aNephrology.
650 2 4 _aPharmacy.
650 2 4 _aPharmaceutical Sciences/Technology.
650 2 4 _aImmunology.
700 1 _aTrouvin, Jean-Hugues.
_eeditor.
710 2 _aSpringerLink (Online service)
773 0 _tSpringer eBooks
776 0 8 _iPrinted edition:
_z9782817803357
856 4 0 _uhttp://dx.doi.org/10.1007/978-2-8178-0336-4
912 _aZDB-2-SME
999 _c96246
_d96246