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Sandoz applies for Japanese approval for biosimilar G-CSF Posted 03/05/2013

Novartis generics unit Sandoz announced on 25 April 2013 that it has filed an application with the Japanese health authority – Pharmaceuticals and Medical Devices Agency (PMDA) – for marketing authorization of EP2006, a biosimilar version of recombinant human granulocyte colony-stimulating factor (G-CSF).

G-CSF, which is also known as filgrastim, is a growth factor used to aid the recovery of bone marrow after chemotherapy treatment for cancer, especially in patients with neutropenia (low white blood cell count in the blood), which causes reduced host defence. It can also be used to stimulate mobilization of haematopoietic stem cells for collection and transplantation.

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. Sandoz also markets biosimilar somatropin (Omnitrope) and biosimilar epoetin alpha (Binocrit) in countries across Europe and elsewhere. Omnitrope, approved as a generic drug under the 505(b)(2) pathway of the Hatch-Waxman Act, is also marketed in the US [1].

This will be Sandoz’s second biosimilar in Japan. The company already has a biosimilar recombinant human growth hormone, somatropin, approved in the country. The biosimilar was approved in June 2009 and was the first biosimilar in Japan [2].

Japan already has biosimilar G-CSFs on the market. The PMDA approved its first biosimilar G-CSF (filgrastim BS) from Mochida Pharmaceutical and Fuji Pharma in November 2012. A second G-CSF biosimilar (filgrastim NK) produced by Nippon Kayaku and development partner Teva Pharmaceutical Industries was approved in March 2013 [3].

Sandoz is the only biosimilars manufacturer to have more than two biosimilars on the market and is set to be a global market leader, with eight to 10 molecules at various stages of development [4].

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References

1.  GaBI Online - Generics and Biosimilars Initiative. Sandoz starts phase III US trial for biosimilar epoetin alfa [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 May 3]. Available from: www.gabionline.net/Biosimilars/Research/Sandoz-starts-phase-III-US-trial-for-biosimilar-epoetin-alfa

2.  GaBI Online - Generics and Biosimilars Initiative. Japanese guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 May 3]. Available from: www.gabionline.net/Guidelines/Japanese-guidelines-for-biosimilars

3.  GaBI Online - Generics and Biosimilars Initiative. Japan approves second biosimilar G-CSF [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 May 3]. Available from: www.gabionline.net/Biosimilars/News/Japan-approves-second-biosimilar-G-CSF

4.  GaBI Online - Generics and Biosimilars Initiative. Everybody jumping on the biosimilars bandwagon [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 May 3]. Available from: www.gabionline.net/Biosimilars/News/Everybody-jumping-on-the-biosimilars-bandwagon

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Source: Sandoz

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