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.


Chapter 1: Current regulatory landscape for biosimilars approval

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.


Chapter 2: Overview of biosimilars development

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.


Chapter 3: Case Studies: EU Regulatory Guidelines and how to interpret them

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.


Chapter 4: Analytical Comparability (chemistry, manufacturing and controls related product attributes)

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.


Chapter 5: Key factors that influence biosimilar in vitro and in vivo nonclinical testing strategies

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.


Chapter 6: Immunogenicity assessment for biosimilars: assay development, validation and interpretation

This chapter reviews the challenges in developing and validating biosimilar immunogenicity assays to support pre-clinical and clinical trials.


Chapter 7: Case studies: challenges of developing and validating PK and immunogenicity assays to support pre-clinical and clinical comparability studies for biosimilars

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.


Chapter 8: Biosimilar monoclonal antibodies

In this chapter biosimilar monoclonal antibodies are introduced and the associated structural and analytical issues are discussed.