Biosimilar Studies: Sample Size

Authored by: Seung-Ho Kang

Encyclopedia of Biopharmaceutical Statistics

Print publication date:  August  2018
Online publication date:  August  2018

Print ISBN: 9781498733953
eBook ISBN: 9781351110273
Adobe ISBN:


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The two-arm equivalence parallel design has been widely utilized to assess the degree of biosimilarity between a biological product and a reference product. The aim is to show that the difference between two population means of a primary end point is less than a prespecified equivalence margin. A well-known sample size formula for the equivalence trial is expressed as follows: H 0 : | μ T − μ R | ≥ δ   versus   H a : | μ T − μ R | < δ

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