Analytical strategies for assessing comparability of biosimilars

Abstract Biosimilar products are required by regulatory authorities to have appropriate and comparable quality, safety and efficacy with a reference biologic product. The analytical techniques that are available to manufacturers of biosimilar medicines are well advanced and present a range of options to characterize the products and compare them with the relevant marketed reference product. This variety of analytical methods can be used to investigate the attributes of a candidate biosimilar and a reference biologic, and ensures that orthogonal methods can be deployed to characterize a single attribute, facilitating rigorous structural characterization and physicochemical evaluation. These analytical methodologies not only enable evidence for bio‐comparability to be amassed but also enable a developer of biosimilars to incorporate risk mitigation into the development strategy. This review discusses the analytical techniques available to support comparability testing, the handling of reference material and the strategic aspects to commercializing biosimilar or follow‐on biological medicinal products. Copyright © 2011 Society of Chemical Industry