Releuko

Filgrastim biosimilar developed by Kashiv BioSciences. Reference product Neupogen.

Brands by market: Releuko (USA) · Commercial partner or holder: Amneal (USA) · Company profile

FDAFeb 2022approved

EMANot listed

MHRANot listed

PMDANot listed

HCNot listed

CDSCONot listed

EDENot listed

Approved or registered in 1 of 7 markets

Connections

Filgrastimmolecule Kashiv BioSciencesdeveloper 1 of 7markets 0trials behind it 1other products, same developer 4rival developers in its markets

About Releuko

Releuko is the filgrastim developed by Kashiv BioSciences and sold in the United States by Amneal, approved in February 2022. It was the third filgrastim biosimilar in the United States, seven years after Zarxio.

Status by market

FDA

United States · Releuko

US Food and Drug AdministrationApproved

Brand

Releuko

Holder or applicant

Kashiv BioSciences, LLC

Pathway

351(k)

Approved

Feb 2022

Application or permission

761082

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

Not listed by EMA.

MHRA

United Kingdom

Not listed by MHRA.

PMDA

Japan

Not listed by PMDA.

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 Releuko holds an approval, these are the other filgrastim biosimilars approved in that market.

Market	Rivals	Developers (product)
FDA	4	Intas Pharmaceuticals (Accofil / Filkri), Pfizer (Nivestym / Nivestim), Sandoz (Zarxio / Zarzio), Tanvex BioPharma (Nypozi)

Same developer, other molecules

Other biosimilars in the Atlas developed by Kashiv BioSciences: Fylnetra.

Chronology

FDAFeb 2022Approved by FDA

Sources

S001FDA, Biosimilar Product Information (approved biosimilars table) Primary (regulator)
S016FDA Purple Book, monthly data downloads January to August 2026 Primary (regulator)

All filgrastim biosimilars

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Data current to September 2026.