On Study of Applications of the Parallel Line Assays to Evaluation of Biosimilar Drug Products
Date Issued
2010
Date
2010
Author(s)
Lin, Ya-Chimg
Abstract
In recent years, biologics market 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 drug products. But biological products are different from traditional small molecule drug products. Therefore the methods for assessment of biosimilar drug products are also different. Innovators ask for clinical trials to provide the efficacy and safety data to approve biosimialr drug products. However if approval of biosimilar products requires clinical trials, then development cost of biosimilar products will be the same as that of the innovators. As a result, it cannot achieve the goal of cost reduction. Therefore we try to apply the method of the parallel line assay to test whether the approval of the biosimilar should require clinical trials and to evaluate the similarity between the biosimilar products and innovator’s biological products. The results of type I error 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
Parallel line assay
Bioequivalence
Extrapolation
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