Nyvepria
Pegfilgrastim biosimilar developed by Pfizer (Hospira), development code PF-06881894. Reference product Neulasta.
About Nyvepria
Nyvepria is Pfizer's pegfilgrastim, developed by its Hospira unit and approved in the United States, Canada and Europe in 2020. It was registered in the UAE in 2024. It sits alongside Nivestym, Pfizer's filgrastim, as a pair for hospital supply.
Status by market
United States · Nyvepria
US Food and Drug AdministrationApprovedEuropean Union · Nyvepria
European Medicines Agency and European CommissionApprovedUnited Kingdom
Not listed by MHRA.
Japan
Not listed by PMDA.
Canada · Nyvepria
Health CanadaApprovedIndia
Not listed by CDSCO.
United Arab Emirates · Nyvepria
Emirates Drug EstablishmentRegisteredTrials behind this product
Comparative trials on ClinicalTrials.gov matched to Nyvepria by development code, brand or developer. Registry data, sponsor-entered.
| Candidate | Developer or sponsor | Reference product | Phase | Design | Registry status | Started | Primary completion | Registry record |
|---|---|---|---|---|---|---|---|---|
| PF-06881894 | Pfizer | Neulasta | Phase 1 | Comparative PK | Completed | Oct 2017 | Jul 2018 | NCT03273842 |
Other developers in the same markets
Where Nyvepria 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), Kashiv BioSciences (Fylnetra), Lupin (Armlupeg / Lupin pegfilgrastim), Sandoz (Ziextenzo) |
| EMA | 7 | Biocon Biologics (Fulphila / Vivlipeg / Biopegfil), Cinfa Biotech (Pelmeg / Cegfila), CuraTeQ Biologics (Dyrupeg / Cavoley), Fresenius Kabi (Stimufend), Intas Pharmaceuticals (Pelgraz / Ennumo), Juta Pharma (Grasustek), Sandoz (Ziextenzo) |
| HC | 4 | Biocon Biologics (Fulphila / Vivlipeg / Biopegfil), Intas Pharmaceuticals (Pelgraz / Ennumo), Nora Pharma (Niopeg), Sandoz (Ziextenzo) |
| EDE | 3 | Biocon Biologics (Fulphila / Vivlipeg / Biopegfil), Intas Pharmaceuticals (Pelgraz / Ennumo), Sandoz (Ziextenzo) |
Same developer, other molecules
Other biosimilars in the Atlas developed by Pfizer: Abrilada / Amsparity, Ixifi / Zessly, Nivestym / Nivestim, Ruxience, Trazimera, Zirabev.
Chronology
- FDAJun 2020Approved by FDA as Nyvepria
- HCOct 2020Notice of Compliance, Health Canada as Nyvepria
- EMANov 2020Authorised by the European Commission as Nyvepria
- EDEMay 2024Registered in the UAE as Nyvepria
Sources
S001FDA, Biosimilar Product Information (approved biosimilars table) Primary (regulator)S016FDA Purple Book, monthly data downloads January to August 2026 Primary (regulator)S017EMA, medicines data table (medicines-output-medicines-report_en.xlsx) Primary (regulator)S018UAE Emirates Drug Establishment, registered medical product directory Primary (regulator)S022Health Canada, Drug Product Database data extract (active and inactive product files, biosimilar table) Primary (regulator)
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