Fylnetra
Pegfilgrastim biosimilar developed by Kashiv BioSciences. Reference product Neulasta.
About Fylnetra
Fylnetra is the pegfilgrastim developed by Kashiv BioSciences and sold in the United States by Amneal, approved in May 2022. Kashiv, based in the United States, develops biosimilars for partners and also developed Amneal's filgrastim, Releuko.
Status by market
United States · Fylnetra
US Food and Drug AdministrationApprovedEuropean Union
Not listed by EMA.
United Kingdom
Not listed by MHRA.
Japan
Not listed by PMDA.
Canada
Not listed by HC.
India
Not listed by CDSCO.
United Arab Emirates
Not listed by EDE.
Other developers in the same markets
Where Fylnetra holds an approval, these are the other pegfilgrastim biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| FDA | 7 | Biocon Biologics (Fulphila / Vivlipeg / Biopegfil), Coherus BioSciences (Udenyca), Fresenius Kabi (Stimufend), Intas Pharmaceuticals (Pelgraz / Ennumo), Lupin (Armlupeg / Lupin pegfilgrastim), Pfizer (Nyvepria), Sandoz (Ziextenzo) |
Same developer, other molecules
Other biosimilars in the Atlas developed by Kashiv BioSciences: Releuko.
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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