Biosimilar Clinical Development: Scientific Considerations and New Methodologies

Biosimilar Clinical Development: Scientific Considerations and New Methodologies provides a comprehensive presentation of scientific considerations and new methodologies in biosimilar clinical development. It discusses state-of-the-art topics such as use of systems biology in biologicals and biosimilars, mechanistic basis of anti-drug antibody generation, interchangeability of biosimilars, clinical assessment metrics and equivalence margin of biosimilarity, and new statistical methods to analyze data from non-inferiority and equivalence clinical trials. The book is designed to give both clinical scientists and statisticians a deeper understanding of biosimilar clinical development. The book also describes the necessary concepts and regulatory guidance for biosimilars. Practical examples and case studies are provided to illustrate applications of new methods. In addition, these methods are compared through simulation. Features, Covers a broad range of scientific topics on biosimilar clinical development, Provides an in-depth understanding of the cellular and molecular mechanises sustaining the immunogenic response, Offers new views of metrics and margins to assess similarity, Features many new statistical analysis methods, including Bayesian decision theory, and their applications in biosimilar clinical development, Explores design and analysis strategies to assess interchangeability of biosimilars, Provides open research problems and questions for both clinical scientists and statisticians Book jacket.