Pegfilgrastim BS Mochida / Nipro
Pegfilgrastim biosimilar developed by Mochida Pharmaceutical. Reference product Neulasta.
Brands by market: Pegfilgrastim BS Mochida and Nipro (Japan) · Commercial partner or holder: Mochida Pharmaceutical
FDAnot listed
EMAnot listed
PMDASep 2023approved
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 · Pegfilgrastim BS Mochida / Nipro
Pharmaceuticals and Medical Devices Agency and MHLWApprovedBrand
Pegfilgrastim BS Mochida / Nipro
Holder or applicant
Mochida Pharmaceutical; Mochida Pharmaceutical Sales
Pathway
Biosimilar (MHLW approval on PMDA review)
Approved
Sep 2023
Indications as licensed
Prevention of febrile neutropenia in cancer chemotherapy
Presentations
3.6 mg subcutaneous injection
Note
Pegfilgrastim Biosimilar 1; reference product G-Lasta, the Japanese brand of Neulasta, at the Japanese 3.6 mg dose.
Source
S020
HC
Canada
Not listed by HC.
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- PMDASep 2023Approved by MHLW
Sources
S020PMDA, list of approved biosimilar products in Japan (as of July 2026) Primary (regulator)
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