Statistical Issues in Comparative Clinical Studies of Biosimilars
*Gregory Levin, Food and Drug Administration 

Keywords: biosimilar, clinical study, margin, endpoint, surrogate, missing data

In this talk, I will focus on the design, conduct, and analysis of the clinical study comparing the safety and effectiveness of the reference product and the proposed biosimilar. I will discuss key issues such as the choice and justification of the similarity margin, endpoint selection and the use of surrogates, prevention and treatment of missing data, and extrapolation of findings from one studied indication to all approved indications.