Filgrastim BS NK
Filgrastim biosimilar developed by Nippon Kayaku. Reference product Neupogen.
Brands by market: Filgrastim BS NK and NIG (Japan) · Commercial partner or holder: Nippon Kayaku · Company profile
FDANot listed
EMANot listed
MHRANot listed
PMDAFeb 2013approved
HCNot listed
CDSCONot listed
EDENot listed
Approved or registered in 1 of 7 markets
Connections
About Filgrastim BS NK
Filgrastim BS NK is Nippon Kayaku's filgrastim, the second approved in Japan, in February 2013. A second name, NIG, was later discontinued.
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union
Not listed by EMA.
MHRA
United Kingdom
Not listed by MHRA.
PMDA
Japan · Filgrastim BS NK
Pharmaceuticals and Medical Devices Agency and MHLWApprovedBrand
Filgrastim BS NK
Holder or applicant
Nippon Kayaku
Pathway
Biosimilar (MHLW approval on PMDA review)
Approved
Feb 2013
Indications as licensed
Neutropenia in chemotherapy, stem cell mobilisation, HIV, MDS, aplastic anaemia, congenital neutropenia
Presentations
75, 150 and 300 microgram syringes
Remarks
Filgrastim Biosimilar 2; the NIG-branded version is discontinued.
Source
S020 (PMDA) · checked Sep 2026
HC
Canada
Not listed by HC.
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Other developers in the same markets
Where Filgrastim BS NK holds an approval, these are the other filgrastim biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| PMDA | 2 | Fuji Pharma (Filgrastim BS F / Mochida), Sandoz (Zarxio / Zarzio) |
Chronology
- PMDAFeb 2013Approved by MHLW
Sources
S020PMDA, list of approved biosimilar products in Japan (as of July 2026) Primary (regulator)
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