The First 2 Biosimilars (Follow on Biologicals) in Japan

Please refer to the new Regulation on Biosimilar in Mar 2009. (Japanese)

There are 2 products in the market now:

1. The first biosimilar in Japan was Sandoz' Somatropin BS. (English news)

The Novartis generics business, Sandoz, launched its recombinant human growth hormone somatropin, Somatropin BS S.C., in Japan. The company says the drug is the first ever biosimilar to be approved and launched in that country, which represents the world’s second largest pharma market.

2. Nippon Chemical Research's EPO was the second biosimilar approved in Japan. (2010 Jan)

Reference:
バイオ後続品の品質・安全性・有効性確保のための指針

バイオ後続品について

質疑応答集　（2010.3.31）

Biosimilars approval status worldwide

動き出すバイオ後続品市場

学術 Q&A Q バイオ後続品とは何ですか