Regulatory PathRegulatory requirements compared

Active substance

Pegfilgrastim

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
Fulphila10 mg/mlSolution for injection · Subcutaneous use1 Pre-filled syringeSAR 1886.10Biological · PrescriptionBiosimilar Collaborations Ireland Limited (BCIL)Valid
Grasustek 6 mg per 0.6 ml10 mg/mlSolution for injection · Subcutaneous use1 Pre-filled syringeSAR 1765.65Biological · PrescriptionJazeera Pharmaceutical Industries (JPI)Valid
NEUCYTE10 mg/mlSolution for injection · Subcutaneous use1 Pre-filled syringeSAR 1765.65Biological · PrescriptionBiocon Biologics LimitedValid
NEULASTIM 6MG-0.6ML PRE-FILLED SYRINGE6 mg/mlSolution for injection · Subcutaneous use1 Pre-filled syringeSAR 2568.25NCE · PrescriptionKYOWA KIRIN LIMITEDValid
Neulasta Onpro6 mgSolution for injection in pre-filled syringe · Subcutaneous use1 Pre-filled syringeSAR 3531.35Biological · PrescriptionKYOWA KIRIN LIMITEDValid
Nyvepria10 mg/mlSolution for injection · Subcutaneous use1 Pre-filled syringeSAR 1765.65Biological · PrescriptionPfizer Europe MA EEIGValid
Pelgraz 6 mg in 0.6 ml10 mg/mlSolution for injection in pre-filled syringe · Subcutaneous use1 Pre-filled syringeSAR 1765.65Biological · PrescriptionBoston Oncology ArabiaValid
Ziextenzo6 mgSolution for injection in pre-filled syringe · Subcutaneous use1 Pre-filled syringeSAR 2095.70Biological · PrescriptionSandoz GmbHValid
NEULASTIM 6MG-0.6ML PRE-FILLED SYRINGE10 mg/mlSolution for injection · Subcutaneous use1 Pre-filled syringeSAR 6100.70NCE · PrescriptionROCHEWithdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

SOFT TISSUE SARCOMA - LEIOMYOSARCOMA & LIPOSARCOMA-ADVERSE REACTION MANAGEMENT; THYROID CANCER-MEDULLARY CARCINOMA-SUPPORTIVE CARE

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
NEULASTA6MG/0.6MLsyringeAMGENPrescription31 Jan 2002
FULPHILA6MG/0.6MLinjectable · injectionMYLAN GMBHPrescription4 Jun 2018
UDENYCA6MG/0.6MLinjectable · injectionCOHERUS BIOSCIENCES INCPrescription2 Nov 2018
ZIEXTENZO6MG/0.6MLinjectable · injectionSANDOZ INCPrescription4 Nov 2019
NYVEPRIA6MG/0.6MLinjectable · injectionHOSPIRA INCPrescription10 Jun 2020
FYLNETRA6MG/0.6MLinjectable · injectionKASHIV BIOSCIENCES LLCPrescription26 May 2022
STIMUFEND6MG/0.6MLsolution · injectionFRESENIUS KABI USAPrescription1 Sep 2022
ARMLUPEG6MG/0.6MLinjection · solutionLUPIN LTDPrescription28 Nov 2025
ENNUMO6MG/0.6MLinjectable · subcutaneousACCORD BIOPHARMA INC.Prescription7 May 2026

EMA European Union — centrally authorised medicines

Neulasta Amgen Europe B.V. · Authorised · authorised 22 Aug 2002 · ATC L03AA13

Therapeutic indication (EMA)

Reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).

Pelgraz Accord Healthcare S.L.U. · Authorised · authorised 21 Sep 2018 · ATC L03AA13

Therapeutic indication (EMA)

Reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).

Pelmeg Mundipharma Corporation (Ireland) Limited · Authorised · authorised 20 Nov 2018 · ATC L03AA13

Therapeutic indication (EMA)

To reduce the duration of neutropenia and the incidence of febrile neutropenia due to chemotherapy.

Fulphila Biosimilar Collaborations Ireland Limited · Authorised · authorised 20 Nov 2018 · ATC L03AA13

Therapeutic indication (EMA)

Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).

Ziextenzo Sandoz GmbH · Authorised · authorised 22 Nov 2018 · ATC L03AA13

Therapeutic indication (EMA)

Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).

Grasustek Juta Pharma GmbH · Authorised · authorised 20 Jun 2019 · ATC L03AA13

Therapeutic indication (EMA)

Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).

Cegfila (previously Pegfilgrastim Mundipharma) Mundipharma Corporation (Ireland) Limited · Authorised · authorised 19 Dec 2019 · ATC L03AA13

Therapeutic indication (EMA)

Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).

Nyvepria Pfizer Europe MA EEIG · Authorised · authorised 18 Nov 2020 · ATC L03AA13

Therapeutic indication (EMA)

Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).

Stimufend Fresenius Kabi Deutschland GmbH · Authorised · authorised 28 Mar 2022 · ATC L03AA13

Therapeutic indication (EMA)

Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).

Dyrupeg CuraTeQ Biologics (Malta) Limited · Authorised · authorised 28 Mar 2025 · ATC L03AA13

Therapeutic indication (EMA)

Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).

Vivlipeg Biosimilar Collaborations Ireland Limited · Authorised · authorised 18 Aug 2025 · ATC L03AA13

Therapeutic indication (EMA)

Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).

Efgratin Gedeon Richter Plc. · Application withdrawn · ATC L03AA13

Therapeutic indication (EMA)

Treatment of neutropenia

Zioxtenzo Sandoz GmbH · Application withdrawn · ATC L03AA13

Therapeutic indication (EMA)

Treatment of neutropenia

Fulphila Mylan S.A.S · Application withdrawn · ATC L03AA13

Therapeutic indication (EMA)

Reducing neutropenia in patients taking cancer treatments

Cavoley STADA Arzneimittel AG · Application withdrawn · ATC L03AA13

Therapeutic indication (EMA)

Treatment of neutropenia

Efgratin Gedeon Richter Plc. · Application withdrawn · ATC L03AA13

Therapeutic indication (EMA)

Treatment of neutropenia.

Cavoley Stada Arzneimittel AG · Application withdrawn · ATC L03AA13

Therapeutic indication (EMA)

Treatment of neutropenia.

Lutholaz YES Pharmaceutical Development Services GmbH · Application withdrawn · ATC L03AA13

Therapeutic indication (EMA)

Treatment of neutropenia

Dyrupeg CuraTeQ Biologics s.r.o · Application withdrawn · ATC L03AA13

Therapeutic indication (EMA)

Treatment of neutropenia.

Nylaspeg Qilu Pharma Spain S.L. · Opinion · ATC L03AA13

Therapeutic indication (EMA)

Reduction of neutropoenia in adults

5 more — full table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
FULPHILA0248415310 MG / MLSOLUTION · SUBCUTANEOUSBIOCON BIOLOGICS CANADA INC
LAPELGA024745656 MG / 0.6 MLSOLUTION · SUBCUTANEOUSAPOTEX INC
LAPELGA025293436 MG / 0.6 MLSOLUTION · SUBCUTANEOUSAPOTEX INC
NEULASTA0224979010 MG / MLSOLUTION · SUBCUTANEOUSAMGEN CANADA INC
NIOPEG025469736 MG / 0.6 MLSOLUTION · SUBCUTANEOUSNORA PHARMA INC
NYVEPRIA025062386 MG / 0.6 MLSOLUTION · SUBCUTANEOUSPFIZER CANADA ULC
PEXEGRA0255394510 MG / MLSOLUTION · SUBCUTANEOUSJAMP PHARMA CORPORATION
ZIEXTENZO024973956 MG / 0.6 MLSOLUTION · SUBCUTANEOUSSANDOZ CANADA INCORPORATED

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACFULPHILA 6 MG/0.6 ML SYRINGE$3369.51per ML23 Sep 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

WHO WHO Model List of Essential Medicines (2025)

  • 8.2.3. Immunomodulators · complementary
    Acquired neutropaenia
    Parenteral > General injections > SC: 6 mg per 0.6 mL in pre-filled syringe

Safety signals and safety-related labeling changes

All safety entries for pegfilgrastim →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.