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.