The approval process has taken almost one year. Sandoz announced on 25 April 2013 that it had filed an application with the Japan’s drug regulatory agency – Pharmaceuticals and Medical Devices Agency – for approval of its biosimilar filgrastim product [1].

Filgrastim 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) in order to accelerate the recovery of infection-fighting white blood cells. It can also be used to stimulate mobilization of haematopoietic stem cells for collection and transplantation.

Filgrastim BS Sandoz is approved in Japan for the same range of indications as the reference product, Kyowa Hakko Kirin’s Gran, and offers patients comparable quality, safety and efficacy.

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

The biosimilar filgrastim from Sandoz has already been used in clinical practice in over 40 countries around the world under the brand name of Zarzio. In fact, Zarzio is the number one biosimilar filgrastim globally. In 2013, it became the most prescribed daily granulocyte colony-stimulating factor (G-CSF) treatment in Europe overtaking originator products from Amgen (Neupogen) and Chugai (Granocyte) in terms of number of prescriptions [3].

Editor’s comment
Readers interested to learn more about Japan’s regulatory developments on biosimilars are invited to visit www.gabi-journal.net to view the following manuscript published in GaBI Journal:

PMDA update: the current situation and future directions

If you are interested in contributing a research paper in a similar area to GaBI Journal, please send us your submission here.

Related articles

Japan approves second biosimilar G-CSF

Approval of first biosimilar G-CSF in Japan

References

1.   GaBI Online - Generics and Biosimilars Initiative. Sandoz applies for Japanese approval for biosimilar G-CSF [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Mar 28]. Available from: www.gabionline.net/Biosimilars/News/Sandoz-applies-for-Japanese-approval-for-biosimilar-G-CSF

2.   GaBI Online - Generics and Biosimilars Initiative. Japanese guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Mar 28]. Available from: www.gabionline.net/Guidelines/Japanese-guidelines-for-biosimilars

3.   GaBI Online - Generics and Biosimilars Initiative. Biosimilar G-CSF prescribed more than originator [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Mar 28]. Available from: www.gabionline.net/Biosimilars/News/Biosimilar-G-CSF-prescribed-more-than-originator

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