Biopharmaceuticals

Research findings from H. Horikawa et al update understanding of biopharmaceuticals

Published in Drug Law Weekly, August 18th, 2009

In this recent study, researchers in Kyoto, Japan conducted a study "To understand the issues around biosimilar development by pharmaceutical companies in Japan, which has emerged as an urgent issue in guaranteeing the availability of affordable biopharmaceuticals and a reduction in drug costs. Various regulatory guidelines related to biosimilar development are carefully reviewed."

"We then interviewed representatives of 11 Japanese companies to explore issues related to the manufacturing, immunogenicity, development costs and regulation of biosimilars. Our investigations show that Japan is unlikely to produce more than a handful of biosimilars domestically in the near...

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Source: Drug Law Weekly (2009-08-18)

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