Biologic drug products are therapeutic moieties that are manufactured using a living system or organism. These are important life-saving drug products for patients with unmet medical needs. They also comprise a growing segment in the pharmaceutical industry. In 2007, worldwide sales of biological products reached $94 billion US dollars, accounting for about 15.56% of the pharmaceuti cal industry’s gross revenue. Meanwhile, many biological products face losing their patents in the next decade. Attempts have been made therefore to establish an abbreviated regulatory pathway for approval of biosimilar drug products, i.e., follow-on (or subsequently entered) biologics of the innovator’s biologic prod- ucts, in order to reduce cost. However, due to the complexity of the structures of biosimilar products and the nature of the manufacturing process, biological products differ from the traditional small-molecule (chemical) drug products. Although the concepts and principles for bioequivalence and interchangeability could be the same for both chemical generics and biosimilar products, scien tific challenges remain for establishing an abbreviated regulatory pathway for approval of biosimilar products due to their unique characteristics.

This is intended to be the first book entirely devoted to the design and analysis of analytical similarity assessment, including tests for similarity in critical quality attributes at various stages of the biosimilar product develop ment manufacturing process. It covers all of the statistical issues that may occur at various stages of biosimilar product research and development. The goal of this book to provide a useful desk reference and a state-of-the art examination of this subject area to (i) scientists and researchers engaged in pharmaceutical/clinical research and development of biologic products, (ii) those in government regulatory agencies who have to make decisions on the review and approval process of biological regulatory submissions, and (iii) biostatisticians who provide the statistical support to the assessment of analytical similarity of biosimilar products. It is my hope that this book can serve as a bridge between the pharmaceutical/biotechnology industry, gov ernment regulatory agencies, and academia