Fylnetra
Pegfilgrastim biosimilar developed by Kashiv BioSciences. Reference product Neulasta.
Brands by market: Fylnetra (USA) · Commercial partner or holder: Amneal (USA)
FDAMay 2022approved
EMAnot listed
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States · Fylnetra
US Food and Drug AdministrationApprovedBrand
Fylnetra
Holder or applicant
Kashiv BioSciences, LLC
Pathway
351(k)
Approved
May 2022
Application or permission
761084
Licence type
351(k) biosimilar, not interchangeable
Presentations
6 mg/0.6 mL PFS
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
- FDAMay 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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