Thursday, June 25, 2009

First Ever Biosimilar Approved in Japan

This post on GEN News discusses how Japanese regulatory authorities have approved the first ever biosimilar, and it is Sandoz biosimilar recombinant human growth hormone somatropin. This comes after Japan released guidelines for national regulatory of biosimilars that mimicked the EU's existing process.

The product will be marketed in Japan as Somatropin BS.C. Injection 5mg/10mg. This Sandoz biosimilar was previously approved in the US and Europe in 2006, but only approved in Japan now.

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