- Chapter 1: Current regulatory landscape for biosimilars approval
- Chapter 2: Overview of biosimilars development
- Chapter 3: Case Studies: EU Regulatory Guidelines and how to interpret them
- Chapter 4: Analytical Comparability (chemistry, manufacturing and controls related product attributes)
- Chapter 5: Key factors that influence biosimilar in vitro and in vivo nonclinical testing strategies
- Chapter 6: Immunogenicity assessment for biosimilars: assay development, validation and interpretation
- Chapter 7: Case studies: challenges of developing and validating PK and immunogenicity assays to support pre-clinical and clinical comparability studies for biosimilars
- Chapter 8: Biosimilar monoclonal antibodies
LingSing K Chen
VP and Global Head of Translational Medicine and Biosimilars
QPS Holdings, Newark, Delaware, USA
About the Author
Dr LingSing Chen is currently serving as Vice President and Global Head of Translational Medicine and Biosimilars at QPS (Delaware, USA), a global GLP- and GCP-compliant CRO supporting Pharma and Biotech companies in discovery, preclinical and clinical drug development worldwide. Since joining QPS in 2005, Dr Chen has played an instrumental role in building and expanding QPS’ capabilities in ligand-binding assays and cell-based assays to assessing PK, immunogenicity, neutralizing antibody activity for large-molecule drug development, as well as biomarkers and pharmacogenomics via various technology platforms. At QPS, her technical teams are devoted to method development, validation and bioanalysis in support of development of biologics, biosimilars, antibody-drug conjugates (ADCs) and oligonucleotide-based drugs. To date, her teams have supported preclinical and clinical bioanalysis for more than 100 NBEs development programs, as well as a dozen or so of biosimilar product-development programs, such as bioequivalence and biosimilarity studies for low-molecular-weight heparins, therapeutic proteins and therapeutic monoclonal antibodies for various therapeutic indications.
Prior to joining QPS, Dr Chen held various research and management positions with increasing leadership roles at Wyeth and other biotech research organizations, where her teams were involved in target discovery and validation, assay development, lead optimization, preclinical development, and clinical pharmacogenetic analysis. Dr Chen received a Ph.D. in molecular biology from Princeton University (New Jersey, USA).
Overview of biosimilars development
Biosimilar product development has become an emerging area of focus in the pharmaceutical industry. Unlike small-molecule generic drugs, biosimilars are complex molecules in structures and functions. 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.
Introduction to biosimilars
An increasing number of patents for innovator biotherapeutics are either already expired or due to expire in the coming years. This creates an exciting commercial opportunity for the development of biosimilars within the pharmaceutical industry. Recent reports have shown that 12 biotherapeutic products with global sales of more than US$67 billion will be exposed to biosimilar competition by 2020, with Humira® (adalimumab) scoring global sales of US$7.9 billion by December 2011 and Enbrel® (etanercept) coming in the second place with global sales of US$7.3 billion . As more blockbuster biotherapeutic drugs approach expiry