Preface: 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. ?밒ntroduction -- Definition of biosimilars -- Pharmaceutical approval?셲 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 medicinal혻 products혻? -- Interchangeability: suggested definition -- Biosimilars??interchangeability and conditions to be implemented -- Interchangeability practices -- Conclusion -- 5. Onco-hematologist point of view ?밎CSFcase -- Biosimilars -- Conclusion -- 6. The oncologist?쁲 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.
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