Statistical Assessment of Biosimilarity based on the Relative Distance between Follow-on Biologics in the (k+ 1)-Arm Parallel Design

Seung-Ho Kang, Wooyoung Shin
2015 Communications for Statistical Applications and Methods  
A three-arm parallel design has been proposed to assess the biosimilarity between a biological product and a reference product using relative distance (Kang and Chow, 2013) . The three-arm parallel design consists of two arms for the reference product and one arm for the biosimilar product. This paper extended the three-arm parallel design to a (k + 1)-arm parallel design composed of k (≥ 3) arms for the reference product and one arm for the biosimilar product. A new relative distance was
more » ... distance was defined based on Euclidean distance; consequently, a corresponding test procedure was developed based on asymptotic distribution. Type I error rates and powers were investigated both theoretically and empirically.
doi:10.5351/csam.2015.22.6.605 fatcat:t34xvwc4afekniy63y3ynfeqfq