Biosimilars: Principles, Regulatory Framework, and Societal Aspects

A “generic” version of a biopharmaceutical may be introduced after patents and other exclusivity rights expire. However, the generic paradigm as it has developed for small molecules over the years cannot be used for biopharmaceuticals. In the European Union (EU) and the United States regulatory systems, the term “biosimilar” was coined for copies of brand-name, originator biopharmaceuticals. This chapter discusses the principles of biosimilar development and the regulatory frameworks that evolved both in the United States and the EU for the development, evaluation, and introduction of biosimilar drug products. In addition, this chapter considers the societal impact of biosimilar introduction together with key challenges and a future outlook.