Japan biopharmaceuticals

Hiroaki Yuasa, Ph.D., Department of Biopharmaceutics, Graduate School of Pharmaceutical Sciences, Nagoya City University, 3-1 Tanabe-dori, Mizuho-ku, Nagoya 467-8603, Japan, Telephone +81 52 836 3423, Fax +81 52 836 3426, E-mail yuasa phar.nagoya-cu.ac.jp... 

Department of Pharmaceutics and Biopharmaceutics Showa Pharmaceutical University Tokyo, Japan... 

The major difference between application of the ICH S6 guideline in the European Union, compared to the United States and Japan, is the rather more complex interaction with the regulatory agencies in relation to agreeing on the preclinical testing strategy for biopharmaceuticals. While sponsor compa-... 

Animal Species Selection Almost all pharmaceutical companies select animal species for preclinical studies on the basis of the results of the responsiveness of a test animal to the biological activity of a biopharmaceutical and its production of neutralizing antibodies. Such considerations are specifically applicable to biopharmaceuticals but not to new chemical entities (NCEs). This survey finding suggests that most pharmaceutical companies in Japan understand and implement the animal species selection in good accordance with ICH S6. 

Types of Biopharmaceuticals Survey data on preclinical safety assessment programs were analyzed for 34 biopharmaceuticals cases. The numbers of antibodies, human proteins, and human protein analogues either in the development or marketed as of 2001 in Japan were 13,12, and 6, respectively. The remainder were bioconjugates, DNA-derived vaccines, and human T cell epitopes. Thus antibodies and human proteins are the two major biopharmaceuticals. 

The safety assessment of biopharmaceuticals in preclinical studies has been improved in Japan with the implementation of the ICH S6. The analysis of data from a questionnaire survey conducted by JPMA suggests that the ICH S6 was well understood and adequately implemented in Japan. The Japanese... 

Department of Biopharmaceutics, Kyoto Pharmaceutical University, Kyoto, Japan... 

StefaanJ.H. Soenen Laboratory of BioNanoColloids, Interdisciplinary Research Center, Katholieke Universiteit Leuven, Kortrijk, Belgium Gert Storm Department of Pharmaceutics, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Utrecht, The Netherlands Ryo Suzuki Department of Biopharmaceutics, School of Pharmaceutical Sciences, Teikyo University, Kanagawa, Japan... 

Department of Biopharmaceutics and Drug Metabolism, Graduate School of Pharmaceutical Sciences, Kyoto University, Sakyo-ku, Kyoto 606-8501, Japan... 

Takagi T, Ramachandran C, Bermejo M, et al. A provisional biopharmaceutical classiEcation of the top 200 oral drag products in the United States, Great Britain, Spain, and Japan. Mol Pharm 2006 3(6) 631-643. 

Takagi, T., Ramachandran, C., Bermejo, M., Yamashita, S., Yu, L.X., and Amidon, G.L. (2006) A provisional biopharmaceutical classification of top 200 oral dmg products in the united states. Great Britain, Spain and Japan. Molecular Pharmaceutics, 6, 631-643. 

Department of Biopharmaceutics Kyoto Pharmaceutical University Misasagi Yamashina-ku, Kyoto, 607-8414 Japan... 

As a result of the national scope of many intellectual property laws, problems sometimes develop where inventions, such as biopharmaceuticals, are traded internationally. International trade can bring divergent national legislation into conflict. Countries that are net exporters of innovations protected by IPRs, such as the United States, the European Union, and Japan, advocate strongly in the international arena for the strengthening of national intellectual property laws and international harmonization of these laws [46]. Although international harmonization... 

Nobuhito Shibata, Department of Biopharmaceutics, Faculty of Pharmaceutical Science, Doshisha Women s College of Liberal Arts, Kyoto, Japan,... 

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