Bioanalysis for Biosimilar Development
ISBN: 978-1-910419-33-5 (Online)
Editor: Paul Declerck (University of Leuven)
This foreword provides an introduction to biosimilars and a breakdown of the content in this eBook.
This chapter reviews the worldwide regulatory framework for biosimilars with special emphasis on European regulations. Comparison of the regulatory requirements and some recommendations regarding global harmonization will be provided.
This chapter presents an overview of the requirements of comparative and biosimilarity testing between the innovator reference products and biosimilars with respect to product quality attributes, nonclinical and clinical studies, and current regulatory guidelines for biosimilar product development.
In this chapter three cases of submitted biosimilar applications are discussed. The aim of the examples and following discussion is to provide insight into the uncertainty that still remains over several factors, including the level of biosimilarity that is deemed acceptable and how to address differences identified during comparative studies.
This chapter summarizes the key considerations when planning and executing comparability studies covering, with examples, the strategic selection of analytical techniques, their applicability and limitations.
This chapter will review the current regulatory landscape with respect to the requirement for nonclinical studies (e.g., pharmacology, PK and toxicology), as well as the design and utility of animal studies.
This chapter reviews the challenges in developing and validating biosimilar immunogenicity assays to support pre-clinical and clinical trials.
In this chapter case studies are presented, which illustrate the assessment of critical assay performance characteristics for both PK and immunogenicity ADA assays to support comparability studies for biosimilar products.
In this chapter biosimilar monoclonal antibodies are introduced and the associated structural and analytical issues are discussed.