Kimzey A, Mease K, Mounho-Zamora B, Wood M. 2021. 13. Biosimilar products—A review of past and current regulatory approval standards for preclinical safety studies. In: Translational Medicine: Optimising Preclinical Safety Evaluation of Biopharmaceuticals. CRC Press: Boca Raton, FL.
Abstract
This chapter provides a general review of biosimilar products and how they differ from generic medicines and why the regulatory pathway for marketing approval for generics is not appropriate for biosimilars. In addition, this chapter reviews the history of the regulatory pathways for the approval of biosimilar products in different regions in the worlds as well as how regulatory standards have evolved over the years and how the current standards have changed compared with the initial guidelines, with specific emphasis on the preclinical studies needed for the demonstration of biosimilarity.