Biosimilars A New Generation of Biologics /

• Corporate Author: SpringerLink (Online service)
• Other Authors: Prugnaud, Jean-Louis. (Editor), Trouvin, Jean-Hugues. (Editor)
• Format: Electronic
• Language: English
• Published: Paris : Springer Paris : Imprint: Springer, 2013.
• Subjects: Medicine.; Immunology.; Pharmaceutical technology.; Pharmacy.; Nephrology.; Oncology.; Medicine & Public Health.; Pharmaceutical Sciences/Technology.
• Online Access: https://ezaccess.library.uitm.edu.my/login?url=http://dx.doi.org/10.1007/978-2-8178-0336-4

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...

Table of Contents:

• 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 approvals 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 oncologists 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.