Pelgraz / Ennumo
Pegfilgrastim biosimilar developed by Intas Pharmaceuticals. Reference product Neulasta.
About Pelgraz / Ennumo
Intas's pegfilgrastim has the longest reach of any Indian pegfilgrastim. It was the first pegfilgrastim biosimilar approved in Europe, as Pelgraz through Accord, in September 2018, and in Canada, as Lapelga through Apotex, earlier that year. It was registered in the UAE in 2021 and reached the United States in May 2026 as Ennumo, the eighth pegfilgrastim biosimilar there.
Status by market
United States · Ennumo
US Food and Drug AdministrationApprovedEuropean Union · Pelgraz
European Medicines Agency and European CommissionApprovedUnited Kingdom · Pelgraz
Medicines and Healthcare products Regulatory AgencyApprovedJapan
Not listed by PMDA.
Canada · Lapelga
Health CanadaApprovedIndia
Not listed by CDSCO.
United Arab Emirates · Pelgraz
Emirates Drug EstablishmentRegisteredTrials behind this product
Comparative trials on ClinicalTrials.gov matched to Pelgraz / Ennumo 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 |
|---|---|---|---|---|---|---|---|---|
| INTP5 | Intas Pharmaceuticals | Neulasta | Phase 1 | Comparative PK | Completed | Feb 2018 | May 2018 | NCT04014062 |
| INTP5 | Intas Pharmaceuticals | Neulasta | Phase 1 | Comparative PK | Completed | Feb 2018 | Jun 2018 | NCT04015232 |
Other developers in the same markets
Where Pelgraz / Ennumo 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), Kashiv BioSciences (Fylnetra), Lupin (Armlupeg / Lupin pegfilgrastim), Pfizer (Nyvepria), Sandoz (Ziextenzo) |
| EMA | 7 | Biocon Biologics (Fulphila / Vivlipeg / Biopegfil), Cinfa Biotech (Pelmeg / Cegfila), CuraTeQ Biologics (Dyrupeg / Cavoley), Fresenius Kabi (Stimufend), Juta Pharma (Grasustek), Pfizer (Nyvepria), Sandoz (Ziextenzo) |
| MHRA | 5 | Biocon Biologics (Fulphila / Vivlipeg / Biopegfil), Cinfa Biotech (Pelmeg / Cegfila), CuraTeQ Biologics (Dyrupeg / Cavoley), Juta Pharma (Grasustek), Sandoz (Ziextenzo) |
| HC | 4 | Biocon Biologics (Fulphila / Vivlipeg / Biopegfil), Nora Pharma (Niopeg), Pfizer (Nyvepria), Sandoz (Ziextenzo) |
| EDE | 3 | Biocon Biologics (Fulphila / Vivlipeg / Biopegfil), Pfizer (Nyvepria), Sandoz (Ziextenzo) |
Same developer, other molecules
Other biosimilars in the Atlas developed by Intas Pharmaceuticals: Accofil / Filkri, Intas bevacizumab, Intas etanercept, Intas follitropin alfa, Intas peginterferon alfa-2b, Intas pertuzumab, Intas rituximab, Intas trastuzumab, Osvyrti / Jubereq, Rexatilux / Razumab, Sondelbay / Intas teriparatide.
Chronology
- HCApr 2018Notice of Compliance, Health Canada as Lapelga
- EMASep 2018Authorised by the European Commission as Pelgraz
- EDEDec 2021Registered in the UAE as Pelgraz
- FDAMay 2026Approved by FDA as Ennumo
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)S023MHRA Products, substance lists of licensed medicines (products.mhra.gov.uk) Primary (regulator)
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