Biosimilar development and regulation in Japan
Journal Title: Generics and Biosimilars Initiative Journal - Year 2013, Vol 2, Issue 4
Abstract
In Japan, biosimilars guidelines following the principles of the EU framework were established by Japan’s Ministry of Health, Labor and Welfare in March 2009. The guidelines cover the manufacturing process, characterization of quality attributes, and clinical and non-clinical studies for biosimilars. In this paper, the requirements for regulatory approval of biosimilars in Japan are outlined.
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GaBI Journal Editor
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- EP ID EP354783
- DOI 10.5639/gabij.2013.0204.055
- Views 118
- Downloads 0
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