BrandWikiReturn

Pegfilgrastim

Pegfilgrastim, sold under the brand name Neulasta among others, is a PEGylated form of the recombinant human granulocyte colony-stimulating factor (GCSF) analog filgrastim.[20] It serves to stimulate the production of white blood cells (neutrophils).[20][21] Pegfilgrastim was developed by Amgen.

Pegfilgrastim treatment can be used to stimulate bone marrow to produce more neutrophils to fight infection in patients undergoing chemotherapy.

Pegfilgrastim has a human half-life of 15 to 80 hours, much longer than the parent filgrastim (3–4 hours).[22][23]

Pegfilgrastim was approved for medical use in the United States in January 2002, in the European Union in August 2002, and in Australia in September 2002.[24][25][26][27][28] It is on the World Health Organization's List of Essential Medicines.[29]

Medical uses

Pegfilgrastim is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in people with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia; and to increase survival in people acutely exposed to myelosuppressive doses of radiation (hematopoietic subsyndrome of acute radiation syndrome).[20][30][31]

Society and culture

Legal status

In January 2025, the Committee for Medicinal Products for Human Use CHMP of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Dyrupeg, intended to shorten the duration of neutropenia and help prevent febrile neutropenia after cytotoxic chemotherapy. The applicant for this medicinal product is CuraTeQ Biologics s.r.o.[32] Dyrupeg is a biosimilar medicinal product that is highly similar to the reference product Neulasta, which was authorized in the EU in August 2002.[32] Dyrupeg was authorized for medical use in the European Union in March 2025.[32][33]

In June 2025, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Vivlipeg, intended to reduce the duration of neutropenia and the incidence of febrile neutropenia after cytotoxic chemotherapy. The applicant for this medicinal product is Biosimilar Collaborations Ireland Limited.[34] Vivlipeg is a biosimilar medicinal product that is highly similar to Neulasta.[34] Vivlipeg was authorized for medical use in the European Union in August 2025.[34][35]

References

  1. Ziextenzo Therapeutic Goods Administration (TGA), 13 December 2019, retrieved 25 August 2020^
  2. Pegfilgrastim Use During Pregnancy Drugs.com, 9 December 2019, retrieved 13 July 2020^
  3. Lupin Receives Approval from U.S. FDA for Biosimilar Armlupeg (Pegfilgrastim-unne) Lupin, 1 December 2025, retrieved 4 December 2025^
  4. Regulatory Decision Summary for Armlupeg Drug and Health Products Portal, 16 August 2024, retrieved 27 December 2024^
  5. Summary Basis of Decision for Armlupeg Drug and Health Products Portal, 22 December 2024, retrieved 25 January 2025^
  6. Cegfila EPAR European Medicines Agency (EMA), 20 December 2019, retrieved 2 April 2020^
  7. Fulphila EPAR European Medicines Agency (EMA), 24 September 2018, retrieved 2 April 2020^
  8. Fylnetra- pegfilgrastim injection DailyMed, 26 May 2022, retrieved 19 June 2022^
  9. Grasustek EPAR European Medicines Agency (EMA), 24 April 2019, retrieved 2 April 2020^
  10. Pelmeg EPAR European Medicines Agency (EMA), 24 September 2018, retrieved 2 April 2020^
  11. Stimufend- pegflilgrastim-fpgk injection, solution DailyMed, 15 September 2022, retrieved 21 January 2023^
  12. Stimufend EPAR European Medicines Agency (EMA), 4 April 2022, retrieved 4 April 2022^
  13. Tezmota NPS MedicineWise, 15 July 2021, retrieved 19 February 2022^
  14. Ziextenzo EPAR European Medicines Agency (EMA), 24 September 2018, retrieved 2 April 2020^
  15. Summary Basis of Decision (SBD) for Ziextenzo Health Canada, 23 October 2014, retrieved 29 May 2022^
  16. Filpegla | Therapeutic Goods Administration (TGA) retrieved 18 December 2022^
  17. Summary Basis of Decision for Niopeg Drug and Health Products Portal, 1 September 2012, retrieved 17 December 2024^
  18. Neulasta Pre-Filled Syringe - Summary of Product Characteristics (SmPC) (emc), 1 June 2021, retrieved 11 October 2021^
  19. Neulasta On Body Injector - Summary of Product Characteristics (SmPC) (emc), retrieved 11 October 2021^
  20. Neulasta- pegfilgrastim kit Neulasta- pegfilgrastim injection DailyMed, retrieved 14 July 2021^
  21. Walsh, G, Spada, S. "Epogen/Procrit" in: Directory of approved biopharmaceutical products. CRC Press, 2005, pp. 136–37.^
  22. Biotechnology and Biopharmaceuticals: Transforming Proteins and Genes into Drugs John Wiley & Sons, 2004, retrieved 10 November 2020^
  23. Pegfilgrastim Monograph for Professionals Drugs.com, 22 August 2019, retrieved 11 June 2020^
  24. Drug Approval Package: Neulasta (Pegfilgrastim) NDA #125031 U.S. Food and Drug Administration (FDA), 25 October 2004, retrieved 11 June 2020^
  25. Neulasta EPAR European Medicines Agency (EMA), 17 September 2018, retrieved 2 April 2020^
  26. Summary for ARTG Entry: 82873 Neulasta pegfilgrastim rbe 6mg/0.6mL injection syringe with stelmi needle shield Therapeutic Goods Administration (TGA)^
  27. NEULASTA pegfilgrastim (Rbe) 6mg/0.6mL injection syringe with automatic needle guard (166387) | Therapeutic Goods Administration (TGA) retrieved 18 December 2022^
  28. NEULASTA pegfilgrastim rbe 6mg/0.6mL injection syringe with stelmi needle shield (82873) | Therapeutic Goods Administration (TGA) retrieved 18 December 2022^
  29. The selection and use of essential medicines 2023: web annex A: World Health Organization model list of essential medicines: 23rd list (2023) World Health Organization, 2023^
  30. Managing neutropenia by pegfilgrastim in patients affected by relapsed/refractory multiple myeloma treated with bendamustine-bortezomib-dexamethasone Supportive Care in Cancer, December 2016^
  31. StatPearls [Internet] StatPearls Publishing, November 2020, retrieved 5 November 2020^
  32. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. Dyrupeg EPAR European Medicines Agency (EMA), 30 January 2025, retrieved 16 February 2025^
  33. Dyrupeg PI Union Register of medicinal products, 31 March 2025, retrieved 26 June 2025^
  34. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. Vivlipeg EPAR European Medicines Agency (EMA), 20 June 2025, retrieved 26 June 2025^
  35. Vivlipeg PI Union Register of medicinal products, 1 September 2025, retrieved 30 September 2025^