Manufacuturing, Development and Regulatory Matters on Biologics, from the Standpoint of the Industory

Abstract

Biologics are important in the pharmaceutical market worldwide, and future growth including biosimilars is expected. On the other hand, it has characteristics different from low molecule drugs in manufacturing development, manufacturing facilities, etc., and there are many problems unique to biologics. Also, some of these issues reflect the trend of global drug development trends, and some are specific to Japan. In this article, from the standpoint of industry, we state opinions regarding manufacturing, development and regulatory matters on biologics to in Japan. Viewpoints include biomanufacturing infrastructure, adaptation to expedited programs on drug development and human resource development for biomanufacturing.