Biosimilar Data Analysis Based on Time-Course of the Clinical Outcomes

• Activity Number: 350
• Type: Contributed
• Date/Time: Tuesday, August 5, 2014 : 10:30 AM to 12:20 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Song Wang*+
• Companies: PPD
• Keywords: Biosimilar ; model-based method ; time-course

Abstract

While regulatory guidance for developing biosimilars have become more established, some ambiguity still exists regarding quantitatively how similar a follow-on product's clinical outcomes must be compared to the reference drug to be considered biosimilar. This leads to some flexibility in applying innovative ways to analyze biosimilar data. Phase III biosimilar clinical trials are typically large and resource-intensive; one reason is that conventional statistical approaches do not utilize all information collected to evaluate similarity on clinical outcomes. To improve the efficiency of phase III biosimilar trials, a model-based approach is proposed to compare the entire time-course of the disease during the treatment period. Several models (Emax, proportional odds ratio etc.) have been investigated; their operating characteristics are compared using simulations. We provide an example trial to illustrate how the model-based methods lead to a smaller sample size for a given power.