title: Applications of the bayesian prior information to evaluation of equivalence of similar biological medicinal products.
abstract: In 2014, there are a number of patents of best-selling biotech drugs around the world about to expire. Large commercial interests will inevitably set off international competition among major pharmaceutical companies. The European Union, the United States, and other countries with advanced medical techniques have paid a high degree of attention to biological similarity (biosimilarity) for drug development and market management and have started to take corresponding measures. Because of the diverse definitions of biosimilarity between countries, which can determine whether the medicines on sale are in the review of the base grant, the competent authority will also encounter varying degrees of standards. Governments should review the corresponding guidelines as soon as possible because many countries around the world have actively amended the law in response to management need of biological similarity. The similarity of biological drugs should be assessed by clinical trial under current regulations. Pharmaceutical companies try to lower the cost of generic drugs to increase the competitiveness of their products. To reduce the number of subjects in the clinical trials for development of generic drugs, we refer to the clinical trial for evaluation of bridging studies. Hsiao et al. (2007) has proposed the use of Bayes method in evaluation of bridging studies. Prior information on the original region is used to reduce the number of subjects to lower the cost of biosimilar drug development. Take the results of the approval biologics as a priori information, and the information is appropriate to be embedded into the model evaluating the similar products in order to reduce the sample size required for the assessment of the test sample.
authors.affiliation: a Department of Biostatistics & Bioinformatics, School of Medicine , Duke University , Durham , North Carolina , USA.
authors.forename: Shih-Ting
authors.initials: ST
authors.lastname: Chiu
authors.forename: Jen-Pei
authors.initials: JP
authors.lastname: Liu
authors.forename: Shein-Chung
authors.initials: SC
authors.lastname: Chow
mesh_terms: D001499:Bayes Theorem; D059451:Biosimilar Pharmaceuticals / Q000493:pharmacokinetics / Q000592:standards / Q000627:therapeutic use; D002986:Clinical Trials as Topic / Q000379:methods / Q000592:standards*; D006801:Humans; D015233:Models, Statistical; D018401:Sample Size; D013810:Therapeutic Equivalency
chemical_list: D059451:Biosimilar Pharmaceuticals
keywords: Bayes method; Biosimilarity; Prior information; Sample size