Biosimilars 101: An Introduction to Biosimilars

Abstract

The surging costs of biological medicines worldwide have necessitated the development of biosimilars. These highly similar versions of off-patent biological products entered the EU in 2006 and the U.S. in 2015. Unlike small molecule generic drugs, which are chemically identical to their originator products, biosimilar products cannot be identical because of the nature of biological molecules. However, as more than a decade of experience in Europe has demonstrated, the slight differences between a biosimilar and its originator do not result in clinically-meaningful differences in the drug’s efficacy and safety. The complexity of biosimilars has led the major regulatory agencies to establish unique biosimilar regulatory protocols. In order to earn approval for these products, biosimilar developers must present thorough analytical characterization packages, pharmacokinetic and pharmacodynamic profiles, and comparative clinical trial data to eliminate any residual uncertainty. Beyond development and regulatory complexities, much of the fascination with biosimilars stems from ongoing efforts to establish unique commercialization blueprints, educate stakeholders, and collect and present real-world evidence from ongoing treatment and post-marketing “switching trials” to demonstrate biosimilars’ safety and efficacy in everyday use. Varying healthcare and reimbursement frameworks worldwide have given rise to dynamic case studies highlighting the diversity of the burgeoning biosimilar market.