Biosimilar Development: Nonclinical and Clinical Strategies and Challenges with a Focus on the Role of PK / PD Assessments

Abstract

Abstract To compare the pharmacokinetic (PK) and/or pharmacodynamic (PD) properties between a proposed biosimilar product and the originator's product, the study(s) should be designed in a way that any difference in the properties could be sensitively detected. This chapter introduces the topic of biosimilarity with a focus on nonclinical and clinical aspects that incorporate PK/PD and immunogenicity considerations including regulatory requirements and study design considerations. The determination of biosimilarity is based on a head‐to‐ head comparison of the proposed biosimilar to the biotherapeutic reference product in terms of quality, safety, and efficacy. These aspects are determined via a hierarchical stepwise process that includes analytical/ biological studies, nonclinical in vivo studies, and clinical studies. The regulatory environment for biosimilars is currently evolving and must be constantly monitored by the biosimilar manufacturers as they work to develop the proposed biosimilar for the global market.