|
Abstract:
|
In recent years there have been a lot of interest to test for similarity between biological drug products, commonly known as biologics. Biologics are large and complex molecule drugs that are produced by living cells and hence these are sensitive to the environmental changes. In addition, biologics usually induce antibodies which raises the safety and efficacy issues. The manufacturing process is also much more complicated and costly than the small-molecule generic drugs. Because of these complexities and inherent variability of the biologics, the testing paradigm of the traditional generic drugs cannot be directly used to test for biosimilarity. Taking into account some of these concerns we propose a set of new metrics to test biosimilarity that takes into consideration of the entire time course of the study and is based on a class of flexible models. The empirical results show that the proposed approach is more sensitive than the classical equivalence test approach, and require much less sample size for detecting biosimilarity.
|
