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Friday, September 14
Fri, Sep 14, 9:15 AM - 9:55 AM
Atrium
Poster Session

Assessing Biosimilarity Using Functional Metrics (300695)

*Lin Dong, North Carolina State University 
Sujit Ghosh, North Carolina State University 

Keywords: Biosimilarity, Rheumatic Arthritis, Nonparametric Methods

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 dynamic model based methodology that takes into consideration the entire time course of the study and is based on a class of flexible models and new functional metrics.The empirical results show that the proposed approach is more sensitive than the classical equivalence test approach which are based on a fixed time point and hence may lead to reduced sample size at the given level of power of a test.