Niopeg
Pegfilgrastim biosimilar developed by Nora Pharma. Reference product Neulasta.
Brands by market: Niopeg (Canada) · Commercial partner or holder: Nora Pharma · Company profile
FDANot listed
EMANot listed
MHRANot listed
PMDANot listed
HCApr 2024approved
CDSCONot listed
EDENot listed
Approved or registered in 1 of 7 markets
Connections
About Niopeg
Niopeg is Nora Pharma's pegfilgrastim, approved in Canada in April 2024. Nora is a Canadian generics company and has not named the developer of the product, which has no counterpart in other markets.
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union
Not listed by EMA.
MHRA
United Kingdom
Not listed by MHRA.
PMDA
Japan
Not listed by PMDA.
HC
Canada · Niopeg
Health CanadaApprovedBrand
Niopeg
Holder or applicant
Nora Pharma INC
Pathway
Biosimilar biologic drug (Notice of Compliance)
Approved
Apr 2024
Application or permission
DIN 02546973
Presentations
6 mg
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 Niopeg holds an approval, these are the other pegfilgrastim biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| HC | 4 | Biocon Biologics (Fulphila / Vivlipeg / Biopegfil), Intas Pharmaceuticals (Pelgraz / Ennumo), Pfizer (Nyvepria), Sandoz (Ziextenzo) |
Chronology
- HCApr 2024Notice of Compliance, Health Canada
Sources
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