A Plus A Statistical Services, LLC, Lansdale, PA, U.S.A.
Stat Med. 2013 Feb 10;32(3):462-9. doi: 10.1002/sim.5564. Epub 2012 Aug 17.
To develop a biosimilar product, it is essential to demonstrate the biosimilarity between the proposed biosimilar product and the reference product first in terms of quality in a stepwise approach that can then help inform the extent of safety and efficacy data that will be required to establish biosimilarity. These comparability studies should have direct side-by-side comparisons of the test and the reference products. In this paper, we develop a statistical method for unpaired head-to-head quality attribute comparisons. The method uses a plausibility interval derived from comparing the reference against the reference itself as the goalpost for claiming comparability. The idea behind this is that any observed difference between the reference and the reference itself should be considered as the random noise and as a part of the variability. We illustrate the performance of the proposed method by using simulation and real data sets.
要开发一种生物类似药产品，首先必须在质量方面逐步证明所提出的生物类似药产品与参照产品具有生物类似性，这有助于确定建立生物类似性所需的安全性和疗效数据的程度。这些可比性研究应直接对试验品和参照品进行并排比较。在本文中，我们开发了一种用于非配对对头质量属性比较的统计方法。该方法使用从参照品与参照品本身的比较中得出的似然区间作为声称可比性的目标。这样做的原因是，参照品与参照品本身之间的任何观察到的差异都应被视为随机噪声，并作为变异性的一部分。我们通过使用模拟数据集和真实数据集来说明所提出方法的性能。
