Role of Pharmacokinetics: Pharmacodynamics in Biosimilar Assessment

  • Antonio da SilvaEmail author
  • Didier Renard


The rapid advancement of recombinant DNA technology throughout the 1980s and the 1990s combined with progress in our scientific and pharmacological understanding of the functions of growth factors, cytokines, and cell receptor proteins in the mediation of human physiology and their eventual role in driving disease led to the development of biologically derived therapies that were either copies of those proteins (e.g., growth factors) or targeted them (e.g., monoclonal antibodies, mAbs). However, the complexity in the development and manufacturing of these biological therapies, aka “biologics,” associated with lack of competition, led to them being priced at very high levels resulting in restrictions to patient accessibility and financial straining of healthcare systems (Kaul..). More recently, the patents associated with those biologics have started to expire, paving the way for the development and commercialization of follow-on biologics, aka biosimilars, that may be marketed at a lower cost than the brand name biologic product improving patient access. The development of biosimilars in highly regulated markets follows a very strict step-by-step pathway that is distinct to that used for the development of small molecule generics. It includes the conduct of pharmacokinetic/pharmacodynamic (PK)/(PD), efficacy, and safety studies in one or more indications to confirm the established high degree of structural and physicochemical similarity to the reference biological and rule out any differences in safety, efficacy, and immunogenicity resulting from any differences in the manufacturing process. This chapter aims to describe the increasingly important role pharmacokinetics and pharmacodynamics assessments play in biosimilar development and how they provide a setting for creative and innovative methods to support the regulatory approval of high quality biologics.


ECG Biosimilar Biologics Modeling & Simulation Pharmacodynamic end-points Bioequivalence 


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Copyright information

© Springer International Publishing Switzerland 2016

Authors and Affiliations

  1. 1.Preclinical Development, Hexal AG, a Sandoz Company part of the Novartis GroupHolzkirchenGermany
  2. 2.Advanced Quantitative Sciences, Novartis Pharma AGBaselSwitzerland

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