ABSTRACT
This chapter reviews regulatory requirements by focusing analytical similarity assessment for the approval pathway of biosimilar products worldwide including World Health Organization (WHO) and various regions, such as European Union, United States, Canada, and Asian Pacific Region such as Japan, Korea, and China. It provides recommendations on global harmonization of regulatory approval pathways. The chapter focuses on several critical and debatable issues in regulatory requirements worldwide. These debatable issues includes heterogeneity of reference product, the assessment of similarity via non-inferiority trials, the potential use of a scaled average bioequivalence criterion for biosimilarity assessment, and intra-batch versus inter-batch biosimilarity assessment. The WHO should continue monitoring progress with the implementation of the guidelines on the evaluation of Similar Biotherapeutic Products (SBP) into regulatory and manufacturers' practices. One of the most important principles of developing SBP is the stepwise approach starting with characterization of quality attributes of the product and followed by non-clinical and clinical evaluations.
