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Japan approves second biosimilar G-CSF Posted 08/03/2013

Japan has granted regulatory approval to a second biosimilar granulocyte colony-stimulating factor (G-CSF).

The biosimilar G-CSF, filgrastim NK, is produced by Nippon Kayaku and development partner Teva Pharmaceutical Industries (Teva). Nippon Kayaku submitted the application for marketing approval to Japan’s Ministry of Health Labour and Welfare (MHLW) for the biosimilar G-CSF back in March 2012.

G-CSF increases the production and function of neutrophils (a type of white blood cell) in the blood. It is therefore used for the treatment of chemotherapy-induced neutropenia (a low number of neutrophils).

Teva currently markets filgrastim in Europe under the trade name Tevagrastim and in the US under the trade name Tbo-filgrastim [1].

Japan approved its first biosimilar G-CSF (Filgrastim BS) in November 2012. The biosimilar was a joint venture from Mochida Pharmaceutical and Fuji Pharma [2]. The biosimilar is not yet available, due to pricing negotiations, but is expected to become commercially available in June 2013, as is Nippon and Teva’s version.

The biosimilar G-CSFs will compete with Kyowa Hakko Kirin’s brand-name filgrastim GRAN (licensed from Kirin-Amgen).

Japan approved its first biosimilar, Sandoz’s Somatropin BS (somatropin), in June 2009 and has also approved a biosimilar epoetin alpha (JCR Pharmaceuticals’ Epoetin alpha BS).

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References

1.  GaBI Online - Generics and Biosimilars Initiative. Teva receives FDA approval for filgrastim in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Mar 8]. Available from: www.gabionline.net/Biosimilars/News/Teva-receives-FDA-approval-for-filgrastim-in-the-US

2.  GaBI Online - Generics and Biosimilars Initiative. Approval of first biosimilar G-CSF in Japan [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Mar 8]. Available from: www.gabionline.net/Biosimilars/News/Approval-of-first-biosimilar-G-CSF-in-Japan

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Source: Biocentury

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