Biosimilar filgrastim gains Japanese approval

Biosimilars/News | Posted 28/03/2014 post-comment0 Post your comment

Sandoz (the generics unit of Novartis) announced on 24 March 2014 that its subsidiary Sandoz Japan had received marketing authorization approval for its biosimilar filgrastim (Filgrastim BS Sandoz).

Approved V13G05

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

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2014 Pro Pharma Communications International. All Rights Reserved.

Source: Sandoz

comment icon Comments (0)
Post your comment
Related content
EC approval of first ustekinumab biosimilar Uzpruvo
IBD 1
Biosimilars/News Posted 16/01/2024
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010