Home/Biosimilar Atlas/Filgrastim/Nivestym / Nivestim

Nivestym / Nivestim

Filgrastim biosimilar developed by Pfizer (Hospira), development code PF-06881893. Reference product Neupogen.

Brands by market: Nivestym (USA); Nivestim (EU) · Commercial partner or holder: Pfizer · Company profile
FDAJul 2018approved
EMAJun 2010authorised
MHRALicenseddate not shown
PMDANot listed
HCApr 2020approved
CDSCONot listed
EDENot listed
Approved or registered in 4 of 7 markets
Connections
FilgrastimmoleculePfizerdeveloper4 of 7markets1trial behind it6other products, same developer6rival developers in its markets

About Nivestym / Nivestim

Nivestim is Pfizer's filgrastim, developed by its Hospira unit and approved in Europe in 2010, where it was the third filgrastim biosimilar. It reached the United States in 2018 as Nivestym and Canada in 2020. It pairs with Nyvepria, Pfizer's pegfilgrastim.

Status by market

FDA

United States · Nivestym

US Food and Drug AdministrationApproved
Brand
Nivestym
Holder or applicant
Hospira Inc., a Pfizer Company
Pathway
351(k)
Approved
Jul 2018
Application or permission
761080
Licence type
351(k) biosimilar, not interchangeable
Reference product in the Purple Book
Neupogen
Marketing status (Purple Book)
Prescription, marketed
Presentations
300 mcg/0.5 mL, 480 mcg/0.8 mL PFS; 300 mcg/mL vials
Source
S001 (FDA); S016 (FDA Purple Book) · checked Sep 2026
EMA

European Union · Nivestim

European Medicines Agency and European CommissionApproved
Brand
Nivestim
Holder or applicant
Pfizer Europe MA EEIG
Pathway
Centralised (Article 10(4))
Approved
Jun 2010
Application or permission
EMEA/H/C/001142
Presentations
see SmPC
Source
S017 (EMA) · checked Sep 2026
MHRA

United Kingdom · Nivestim

Medicines and Healthcare products Regulatory AgencyApproved
Brand
Nivestim
Holder or applicant
Not shown in the MHRA substance list
Pathway
UK marketing authorisation (Great Britain and, for EU-converted licences, Northern Ireland)
Approved
not published
Presentations
12, 30 and 48 MU
Source
S023 (MHRA Products) · checked Sep 2026
PMDA

Japan

Not listed by PMDA.

HC

Canada · Nivestym

Health CanadaApproved
Brand
Nivestym
Holder or applicant
Pfizer Canada ULC
Pathway
Biosimilar biologic drug (Notice of Compliance)
Approved
Apr 2020
Application or permission
DIN 02485575, 02485583, 02485591, 02485656
Presentations
300, 480 micrograms
Source
S022 (Health Canada) · checked Sep 2026
CDSCO

India

Not listed by CDSCO.

EDE

United Arab Emirates

Not listed by EDE.

Trials behind this product

Comparative trials on ClinicalTrials.gov matched to Nivestym / Nivestim by development code, brand or developer. Registry data, sponsor-entered.

CandidateDeveloper or sponsorReference productPhaseDesignRegistry statusStartedPrimary completionRegistry record
Filgrastim HospiraPfizerNeupogenPhase 1Comparative PKCompletedOct 2016Jan 2017NCT02923791

Other developers in the same markets

Where Nivestym / Nivestim holds an approval, these are the other filgrastim biosimilars approved in that market.

MarketRivalsDevelopers (product)
FDA4Intas Pharmaceuticals (Accofil / Filkri), Kashiv BioSciences (Releuko), Sandoz (Zarxio / Zarzio), Tanvex BioPharma (Nypozi)
EMA4CuraTeQ Biologics (Zefylti), Intas Pharmaceuticals (Accofil / Filkri), Sandoz (Zarxio / Zarzio), Teva (Tevagrastim / Ratiograstim)
MHRA3CuraTeQ Biologics (Zefylti), Intas Pharmaceuticals (Accofil / Filkri), Sandoz (Zarxio / Zarzio)
HC2Intas Pharmaceuticals (Accofil / Filkri), Tanvex BioPharma (Nypozi)

Same developer, other molecules

Other biosimilars in the Atlas developed by Pfizer: Abrilada / Amsparity, Ixifi / Zessly, Nyvepria, Ruxience, Trazimera, Zirabev.

Chronology

Sources

All filgrastim biosimilars

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Data current to September 2026.