Thursday, April 25, 2013

Sandoz Files Biosimilar G-CSF for approval in Japan

Sandoz has filed an application with the Japanese health authority (PMDA) for marketing authorization of EP2006, a biosimilar version of recombinant human granulocyte colony stimulating factor (G-CSF). If approved, EP2006 would be the third G-CSF biosimilar in Japan. Earlier this year Japan regulators approved biosmilar G-CSF from Teva and Nippon Kayaku. Japan approved its first biosimilar G-CSF (Filgrastim BS) in November 2012. The biosimilar was a joint venture from Mochida Pharmaceutical and Fuji Pharma 

Assuming a 1 year review time like in case of Teva / Nippon Kayaku, Sandoz G-CSF biomilar should reach the Japan market by May 2014 .  EP2006 has already been on the global market since 2009 and is now marketed in more than 40 countries around the world including Europe under the brand name of Zarzio®.  Zarzio® is the number one biosimilar filgrastim globally and it is estimated that the product has been prescribed to more than 100,000 patients worldwide.

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