Statistical Approaches to Demonstrate Analytical Similarity of Quality Attributes
*Cassie Dong, FDA Keywords: biosimilar, equivalencet test, equivalence margin Compared to drugs which are usually small molecules, biologic products have much more complicated structures and manufacturing process. Thus, unlike generic drugs where the active ingredients are identical to the reference product, biosimilars are similar to the reference product in terms of quality, efficacy and safety. The development of biosimilars consists of analytical, non-clinical and/or clinical studies. As the fundamental part in the development process, analytical similarity assessment consists of a comprehensive comparison of the physicochemical attributes and biological activities between the biosimilar and the reference products. Statistical equivalence testing plays a critical role in providing quantitative assessment for analytical biosimilarity. In this talk, we will start with an introduction of analytical biosimilarity assessment, followed by the application of statistical equivalence testing in this process. The data set from Zarxio, the 1st approved biosimilar product in the United States, will be presented as an example.
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Key Dates
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June 3, 2014 - September 7, 2015
Online Registration -
June 3, 2015 - August 15, 2015
Housing -
July 31 - August 17, 2015
Invited Abstract Editing -
August 10, 2015
Short Course materials due from Instructors -
August 26, 2015
Advanced Registration Deadline -
September 7, 2015
Cancellation Deadline -
September 16 - 18, 2015
Marriott Wardman Park, Washington, DC