Simultaneous Assessment of Biosimilarity Between Two Biological Products

• Activity Number: 699
• Type: Contributed
• Date/Time: Thursday, August 13, 2015 : 10:30 AM to 12:20 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Hsiao-Hui Tsou* and Chin-Fu Hsiao and Jung-Tzu Liu and Chi-Tian Chen and Yi-Hsuan Lai and Wan-Jung Chang and Chyng-Shyan Tzeng
• Companies: National Health Research Institutes and National Health Research Institutes and National Health Research Institutes and National Health Research Institutes and Delta Electronics, Inc. and National Health Research Institutes and National Tsing Hua University
• Keywords: biosimilarity ; multiple-arm parallel design ; qualitative method ; simultaneous assessment ; quantitative method

Abstract

In recent years, a variety of expensive brand biological drugs, such as Neupogen for neutropenia, Remicade for rheumatoid arthritis, and Herceptin for breast cancer, go off patent. The development of biosimilars (also called follow-on biologics) is increasing with great enthusiasm. In this presentation, a qualitative method and a quantitative method are introduced to assess if observed treatment effect are within an acceptable range for claiming the biosimilarity of the treatment effects between the two biological products. The sample size formula is derived to judging whether the biosimilar drug is similar to the innovator drug. The type I error rates and powers of the proposed approach are investigated empirically. The comparison between the two method and the other existing methods is studied through simulation. The proposed complex design can be simply applied to a parallel two arm design. An example is given for illustrating the application of the proposed approach.