Releuko
Filgrastim biosimilar developed by Kashiv BioSciences. Reference product Neupogen.
Brands by market: Releuko (USA) · Commercial partner or holder: Amneal (USA)
FDAFeb 2022approved
EMAnot listed
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States · Releuko
US Food and Drug AdministrationApprovedBrand
Releuko
Holder or applicant
Kashiv BioSciences, LLC
Pathway
351(k)
Approved
Feb 2022
Application or permission
761082
Licence type
351(k) biosimilar, not interchangeable
Presentations
300 mcg/0.5 mL, 480 mcg/0.8 mL PFS; 300 mcg/mL vials
Source
S001, S016
EMA
European Union
Not listed by EMA.
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
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)
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