A Study for Application of the Parallel-line Assay to Evaluation of Biosimilar Drug Products Based on Censored Data
Date Issued
2013
Date
2013
Author(s)
Chang, Yu-Cheng
Abstract
In recent years, biologics market of biological drug increases rapidly, but the development costs are also very high. Therefore, after the patent of biological products expires, many pharmaceutical companies have invested in the development of biosimilar products. But, biological products, with process specificity, are different from traditional small molecule drug products. Therefore the methods for assessment of biosimilar products are also different from that of chemical generic products. Current regulations indicate that the clinical trials for assessment can be waived on a case-by-case basis, but a pharmacovigilance is necessary. However, if the requirement for clinical trials cannot be waived, the development cost of biosimilar products will be the same as that of the innovators. It cannot achieve the goal of cost reduction, and deny of access of biological drug products to needed patients. In this thesis, we propose to apply the parallel-line assay to test whether the approval of the biosimilar products should require clinical trials. We developed the statistical testing procedure to evaluate the equivalence between the biosimilar drug product and innovator’s biological procedure when the primary endpoint is a censored variable which follows an exponential distribution. The results of size and power from the simulation studies are presented. A numerical example is used to illustrate the application of the proposed method.
Subjects
Biological products
Biosimilar
Censored endpoints
Exponential distribution
Type
thesis
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