Biosimilars A New Generation of Biologics /
Biologics 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 co...
| Συγγραφή απο Οργανισμό/Αρχή: | |
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| Άλλοι συγγραφείς: | , |
| Μορφή: | Ηλεκτρονική πηγή Ηλ. βιβλίο |
| Γλώσσα: | English |
| Έκδοση: |
Paris :
Springer Paris : Imprint: Springer,
2013.
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| Θέματα: | |
| Διαθέσιμο Online: | Full Text via HEAL-Link |
Πίνακας περιεχομένων:
- 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. –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.
