In analytical similarity assessment of a biosimilar product, key quality attributes of the test and reference products need to be shown statistically similar. When there were multiple references, similarity among the reference products is also required. We proposed a simultaneous confidence approach based on the fiducial inference theory as an alternative to the pairwise comparison method. Three versions with two types of simultaneous confidence intervals for each version were proposed based on different assumptions of the population variance. We conducted extensive simulation studies to compare the performance of our proposed method and the pairwise method, and provided examples to illustrate the concern of using pairwise method.

在生物仿制药产品的分析相似性评估中，需要在统计上显示测试产品和参考产品的关键质量属性。当有多个参考文献时，也需要参考产品之间具有相似性。我们提出了一种基于基准推理理论的同时置信方法，作为成对比较方法的一种替代方法。根据总体方差的不同假设，提出了三个版本，每个版本具有两种同时置信区间。我们进行了广泛的仿真研究，比较了我们提出的方法和成对方法的性能，并提供了一些实例来说明使用成对方法的问题。