TL06: Statistical Considerations in Trial Design and Sample Size Estimation for Assessing Biosimilarity and Interchangeability
*Shuhong Zhao, Inventiv Health 

Keywords: Clinical endpoints, Sample Size, Biosimilarity, Interchangeability.

In recent years, assessing biosimilarity and interchangeability has become more and more attractive to manufacturers or pharmaceutical companies. Given the lack of available guidance from regulatory agencies on such trial designs, we would like to share and discuss with other statisticians about current statistical considerations in term of endpoint selection and sample size determination for phase 3 trials that are targeted to assess both biosimilarity and interchangeability of study drugs compared to an active control.