ABSTRACT
This chapter reviews two recent biosimilar regulatory submissions voted approval by the Oncologic Drugs Advisory Committee meeting held in Silver Spring on July 13, 2017 as case studies of the abbreviated licensure pathway developed by the Food and Drug Administration (FDA). It outlines commonly adopted strategies for biosimilar regulatory submissions. The chapter discusses the case of Amgen's Avastin biosimilar regulatory submission by focusing on similarity assessment of data collected from the analytical studies. It introduces the mechanism of action of the United States-licensed reference product, analytical data generation, results of analytical similarity assessment, and FDA’s assessment of analytical data. The chapter also discusses the case of Mylan's Herceptin biosimilar regulatory submission by focusing on similarity assessment of data collected from the analytical studies. It also introduces pathophysiology of HER2 and mechanism of action of trastuzumab, analytical data generation, results of analytical similarity assessment, and FDA's assessment of analytical data.
