Statistical Methodology for Evaluation of Biosimilarity in Biological Products

In recent years, patents of many early biological products will be expired and this provides the opportunity to manufacture the generic versions of the biological products, which are referred to the biosimilar products. The US Food and Drug Administration (FDA) released on February 9, 2012, drafts of three new guidance documents about the demonstration of biosimilarity. Therefore, competition of cost-effective biosimilar products with equivalent efficacy and safety can reduce the costs and affordability of the biosimilar products to the average patients may be possible in the next few years. On the other hand, the complexity and variability of the molecular structure, complicated manufacturing processes, proper statistical analysis methods for evaluation of biosimilarity between the biosimilar products and their corresponding innovator product a great challenge for statisticians and regulatory agencies. Hence, this research proposal will be devoted to develop the statistical methodology for evaluation the extrapolation of the similarity in product characteristics based on the censored endpoints.

Project ID:PA10307-0655
External Project ID:MOST103-2118-M182-001