Assessment of Biosimilar Products Using a Biosimilarity Index Based on a Tolerance Interval Approach

• Activity Number: 487
• Type: Contributed
• Date/Time: Wednesday, August 7, 2013 : 8:30 AM to 10:20 AM
• Sponsor: Biopharmaceutical Section
• Author(s): Chinfu Hsiao*+ and Hsiao-Hui Tsou
• Companies: National Health Research Institutes and National Health Research Institutes
• Keywords: Biosimilars ; tolerance interval ; innovator biologic

Abstract

In recent years, biosimilars have received increasing attention from sponsors and regulatory authorities while more biological products will lose their patent protection in the next few years. Unlike the chemically synthesized drugs, the development of biologic products is much different and more complicated because of the fundamental differences in functional structure and manufacturing process. Thus, the standard statistical methods for the assessment of average bioequivalence may not be appropriate for the assessment of biosimilarity of biosimilars. In this presentation, we will use a tolerance interval approach for assessment of biosimilarity between a biosimilar product and the innovator biologic for continuous outcomes. Methods for sample size determination to ensure the tolerance interval to have enough degree of stability, and consequently to assess the similarity of biosimilar products are also proposed. In addition, we conduct simulation studies to evaluate the performance of the proposed method and gave some numerical examples to illustrate applications of the proposed approach.