Mochida Pharmaceuticals (Mochida) and development partner Fuji Pharma announced on 21 November 2012 that they had gained approval for the first biosimilar granulocyte colony-stimulating factor (G-CSF) in Japan.
Approval of first biosimilar G-CSF in Japan
Biosimilars/News
|
Posted 30/11/2012
0
Post your comment

The Japanese biotechnology firms started joint development of the biosimilar G-CSF back in February 2010, and had filed respective applications to Japan’s Ministry for Health Labour and Welfare (MHLW) for approval of their biosimilar G-CSF in December 2011 [1].
G-CSF has the effect of increasing the production and function of neutrophils in the blood. It is a physiologically active protein that is used for the treatment of neutropenia (a low number of neutrophils) caused by cancer chemotherapy.
The biosimilar (syringe filgrastim BS), which will be marketed under separate brand names by the two companies, has been approved in prefilled syringes containing 75 mg, 150 mg and 300 mg filgrastim. In their joint press release Mochida and Fuji Pharma stated that they believed the drug ‘can contribute to the improvement of patient quality of life’.
The biosimilar will not, however, be released immediately, as it first has to undergo a pricing process in order for the drug to be included in the National Health Insurance Drug Price List and thus be eligible for reimbursement.
Related articles
Japanese firms developing biosimilars
Japanese guidelines for biosimilars
Gedeon Richter sign biosimilars’ agreement with Mochida
Reference
1. GaBI Online - Generics and Biosimilars Initiative. First biosimilar G-CSF in Japan [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 November 30]. Available from: www.gabionline.net/Biosimilars/News/First-biosimilar-G-CSF-in-Japan
Permission granted to reproduce for personal and educational 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.
Source: Fuji Pharma, Mochida
Research
Biosimilars in low- and middle-income countries
Positive safety and efficacy primary endpoint results for AVT05 (golimumab proposed biosimilar)
General
The ustekinumab shift: biosimilars displace Stelara’s market leadership
Brazilian law establishes December 16 as National Biosimilar Day
EC approves eight biosimilars, eight more await final authorization

Biosimilars/News Posted 18/02/2025
The best selling biotechnology drugs of 2008: the next biosimilars targets

Post your comment