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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 · Company profile
FDANot listed
EMANot listed
MHRANot listed
PMDASep 2023approved
HCNot listed
CDSCONot listed
EDENot listed
Approved or registered in 1 of 7 markets

About Pegfilgrastim BS Mochida / Nipro

Pegfilgrastim BS Mochida is the first and only pegfilgrastim biosimilar approved in Japan, in September 2023, also sold under Nipro's name. It is dosed at the Japanese standard of 3.6 mg rather than the 6 mg used elsewhere, against the Japanese reference brand G-Lasta.

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 · Pegfilgrastim BS Mochida / Nipro

Pharmaceuticals and Medical Devices Agency and MHLWApproved
Brand
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
Remarks
Pegfilgrastim Biosimilar 1; reference product G-Lasta, the Japanese brand of Neulasta, at the Japanese 3.6 mg dose.
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.

Same developer, other molecules

Other biosimilars in the Atlas developed by Mochida Pharmaceutical: Adalimumab BS MA, Etanercept BS MA, Teriparatide BS Mochida, Tocilizumab BS MA.

Chronology

Sources

All pegfilgrastim biosimilars

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Data current to September 2026.