Nypozi
Filgrastim biosimilar developed by Tanvex BioPharma, development code TX01. Reference product Neupogen.
Brands by market: Nypozi (USA) · Commercial partner or holder: Tanvex BioPharma · Company profile
FDAJun 2024approved
EMANot listed
MHRANot listed
PMDANot listed
HCOct 2021approved
CDSCONot listed
EDENot listed
Approved or registered in 2 of 7 markets
Connections
About Nypozi
Nypozi is the filgrastim developed by Tanvex BioPharma of Taiwan, approved in Canada in 2021 and in the United States in June 2024. It was Tanvex's first approval in either market.
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
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
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.
HC
Canada · Nypozi
Health CanadaApprovedBrand
Nypozi
Holder or applicant
Tanvex Biopharma Usa, INC.
Pathway
Biosimilar biologic drug (Notice of Compliance)
Approved
Oct 2021
Application or permission
DIN 02520990, 02521008
Presentations
300, 480 micrograms
Source
S022 (Health Canada) · checked Sep 2026
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Other developers in the same markets
Where Nypozi holds an approval, these are the other filgrastim biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| FDA | 4 | Intas Pharmaceuticals (Accofil / Filkri), Kashiv BioSciences (Releuko), Pfizer (Nivestym / Nivestim), Sandoz (Zarxio / Zarzio) |
| HC | 2 | Intas Pharmaceuticals (Accofil / Filkri), Pfizer (Nivestym / Nivestim) |
Chronology
- HCOct 2021Notice of Compliance, Health Canada as Nypozi
- FDAJun 2024Approved by FDA as Nypozi
Sources
S001FDA, Biosimilar Product Information (approved biosimilars table) Primary (regulator)S016FDA Purple Book, monthly data downloads January to August 2026 Primary (regulator)S022Health Canada, Drug Product Database data extract (active and inactive product files, biosimilar table) Primary (regulator)
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