Establishing comparability of an originator and its biosimilar at the structural and functional level, by analyzing so-called quality attributes, is an important step in biosimilar development. We propose the 'tail-test' to improve the alignment of statistical hypothesis testing with scientific judgment by shifting away from the often-used comparison of mean values toward a range-based comparison. A web-based tool is hosted at https://nballarini.shinyapps.io/tailTest/
The tail-test is described in Mielke J, Innerbichler F, Schiestl M, Ballarini NM, Jones B. The Assessment of Quality Attributes for Biosimilars: a Statistical Perspective on Current Practice and a Proposal. The AAPS journal. 2019 Jan 1;21(1):7. DOI: 10.1208/s12248-018-0275-9.
# You can install the tailTest package from its github repository
# install.packages("devtools")
devtools::install_github("nicoballarini/tailTest")