Nypozi
Filgrastim biosimilar developed by Tanvex BioPharma, development code TX01. Reference product Neupogen.
Brands by market: Nypozi (USA) · Commercial partner or holder: Tanvex BioPharma
FDAJun 2024approved
EMAnot listed
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States · Nypozi
US Food and Drug AdministrationApprovedBrand
Nypozi
Holder or applicant
Tanvex BioPharma USA, Inc.
Pathway
351(k)
Approved
Jun 2024
Application or permission
761126
Licence type
351(k) biosimilar, not interchangeable
Presentations
300 mcg/0.5 mL, 480 mcg/0.8 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
- FDAJun 2024Approved 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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