On Study of Applications of the Logistic Regression to Evaluation of Equivalence of Similar Biological Medicinal Products
Date Issued
2011
Date
2011
Author(s)
Chang, Chih-Hsi
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 products. But, biological products, with process specificity, are different from traditional small molecule drug products. Thought the methods for assessment of biosimilar products are also different. 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, and it cannot achieve the goal of cost reduction.
In this thesis, we try to apply the logistic regression 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 when the primary endpoint as a binary variable. 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
生物製劑
生物製劑相似性藥品
羅吉斯回歸
Type
thesis
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