Application of an Adaptive Analytical Characterization Strategy to Support Development and Approval of Biosimilars

Abstract

Availability of biosimilar drugs in the United States and other regions of the world plays an important role in decreasing drug prices and increasing access to life-enhancing therapies. To ensure safety, efficacy, and bioequivalence of these biologically-derived products, their commercialization pathway is governed by stringent, and sometimes region-specific, clinical and quality requirements. Biosimilars represent a unique class of biopharmaceuticals in which the clinical commercialization pathway is streamlined, but the stringency of analytical characterization remains high. Comprehensive analytical characterization is required to demonstrate analytical similarity of numerous quality attributes between the biosimilar and reference products. In this chapter, the authors present an overarching, yet adaptive, analytical characterization strategy intended to satisfy world-wide regulatory expectations for approval of protein-based biosimilars in key regions of the world with known requirements for marketing authorization. The authors then demonstrate how analytical characterization methods may be managed within a broad and general lifecycle characterization framework. It is the authors’ belief that a carefully designed characterization strategy, such as the one recommended in this chapter, will enable more rapid development of high-quality biosimilar drugs and aid in successfully bringing them to market.