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Abstract:
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Biosimilar is a biological product that is highly similar to and no clinically meaningful difference from an existing approved reference drug. Unlike generic drug, biosimilars are made of or derived from living cells or organisms, therefore, they are often sensitive to small changes and variation during the manufacturing process. Consequently, to conclude biosimilarity, it may not be appropriate to just focus mean difference or ratio of means but ignore the variabilities associated with the test and reference products. As a result, it is important to monitor the whole distribution of the clinical outcomes. In this research, we propose to use the concept of tolerance intervals and related hypothesis testing for assessing biosimilarity. The merit of this concept is that we have established a criterion for assessing biosimilarity by considering the entire distributions associated with both groups. A real example is used to illustrate the propose methods. This approach is more stringent than that of confidence intervals approach in assessing biosimilarity in some cases.
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