Extended Nonparametric Tests for Evaluation of Biosimilarity in Variability to Assess Follow-On Biologics

• Activity Number: 47
• Type: Invited
• Date/Time: Sunday, August 1, 2010 : 4:00 PM to 5:50 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Nan Zhang*+ and Jun Yang and Shein-Chung Chow and Eric M. Chi
• Companies: Amgen Inc. and Amgen Inc. and Duke University School of Medicine and Amgen Inc.
• Keywords: Follow-on Biologics ; Biosimilars ; Extended Non-parametric Test ; Extended F-test ; Biosimilarity in Variability

Abstract

As more biologic products are going off patent protection, the development of follow-on biologic products (biosimilars) has gained much attention from both biotechnology industry and regulatory agencies. Unlike small molecules, the development of biologic products is extremely sensitive to the manufacturing process/environment. Thus, Chow and Liu (2009) suggested that the assessment of biosimilarity between biologic products should be conducted based on variability, in addition to average of endpoints of interest. Here, we extend the traditional non-parametric tests for homogeneity of variances to evaluation of biosimilarity in variability between FoBs. Extensive simulation studies are conducted to compare the relative performance of the proposed methods with the extended F-test evaluated by Yang et al. (2009) in terms of consistency for correctly concluding biosimilarity in variability.