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
FDAnot listed
EMAnot listed
PMDAFeb 2013approved
HCnot listed
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union
Not listed by EMA.
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
Note
Filgrastim Biosimilar 2; the NIG-branded version is discontinued.
Source
S020
HC
Canada
Not listed by HC.
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- PMDAFeb 2013Approved by MHLW
Sources
S020PMDA, list of approved biosimilar products in Japan (as of July 2026) Primary (regulator)
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