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Activity Number: 335
Type: Contributed
Date/Time: Tuesday, August 5, 2014 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract #312685
Title: Assessing Biosimilarity of a Follow-On Biologics
Author(s): Hsiao-Hui Tsou*+ and Chinfu Hsiao and Chi-Tian Chen and Yi-Hsuan Lai
Companies: National Health Research Institutes and National Health Research Institutes and National Health Research Institutes and Delta Electronics
Keywords: biosimilarity ; follow-on biologics ; innovator biologic ; consistency
Abstract:

The development of follow-on biologics products has received much attention from both sponsors and regulatory authorities while more biologic products are losing 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. The European Medicines Agency (EMEA) of EU and the US Food and Drug Administration (FDA) had published guidances on biosimilar product development to assist industry in developing such products. However, no specific statistical methods for assessment of biosimilarity were mentioned in the guidences. In this study, we focused on evaluating the consistency of the treatment effects from the reference drug and the biosimilar. We developed a new approach for the assessment of the consistency and illustrated the application by examples. We proposed method for sample size determination to ensure enough probability (eg., 80%) of consistency between the biosimilar and the innovator biologic. Numerical examples were given to evaluate the performance of the proposed method.


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