Pegfilgrastim, sold under the brand name Neulasta among others, is a

PEGylated PEGylation (or pegylation) is the process of both covalent and non-covalent attachment or amalgamation of polyethylene glycol (PEG, in pharmacy called macrogol) polymer chains to molecules and macrostructures, such as a drug, therapeutic protein ...

form of the recombinant human

granulocyte colony-stimulating factor Granulocyte colony-stimulating factor (G-CSF or GCSF), also known as colony-stimulating factor 3 (CSF 3), is a glycoprotein that stimulates the bone marrow to produce granulocytes and stem cells and release them into the bloodstream. Functiona ...

(GCSF) analog

filgrastim Filgrastim, sold under the brand name Neupogen among others, is a medication used to treat low neutrophil count. Low neutrophil counts may occur with HIV/AIDS, following chemotherapy or radiation poisoning, or be of an unknown cause. It may ...

. It serves to stimulate the production of white blood cells ( neutrophils). Pegfilgrastim was developed by

Amgen Amgen Inc. (formerly Applied Molecular Genetics Inc.) is an American multinational biopharmaceutical company headquartered in Thousand Oaks, California. One of the world's largest independent biotechnology companies, Amgen was established in T ...

. 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). 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.

Medical uses

Pegfilgrastim is

indicated In medicine, an indication is a valid reason to use a certain test, medication, procedure, or surgery. There can be multiple indications to use a procedure or medication. An indication can commonly be confused with the term diagnosis. A diagnosis ...

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).

Biosimilars

Ristempa was approved for medical use in Australia in January 2017. Tezmota was approved for medical use in Australia in March 2018. Pegfilgrastim-jmdb (Fulphila) was approved for medical use in the United States in June 2018. Fulphila was approved for medical use in Australia in August 2018. Pelgraz was approved for medical use in the European Union in September 2018. Udenyca was approved for medical use in the European Union in September 2018. On November 2, 2018, Coherus Biosciences received FDA approval for its biosimilar, pegfilgrastim-cbqv (Udenyca). The push to receive approval and begin production of Udenyca was due in large part to the quickly increasing cost of Neulasta, which has nearly tripled since its release in 2002. Pelmeg was approved for medical use in the European Union in November 2018. Fulphila was approved for medical use in the European Union in November 2018. Ziextenzo was approved for medical use in the European Union in November 2018. Fulphila was approved for medical use in Canada in December 2018. Grasustek was approved for medical use in the European Union in June 2019. Ziextenzo was approved for medical use in Australia in July 2019. Pelgraz was approved for medical use in Australia in August 2019. Lapelga and Neutropeg were approved for medical use in Australia in August 2019. Pegfilgrastim-bmez (Ziextenzo) was approved for medical use in the United States in November 2019. Cegfila was approved for medical use in the European Union in December 2019. Ziextenzo was approved for medical use in Canada in April 2020. Pegfilgrastim-apgf (Nyvepria) was approved for medical use in the United States in June 2020. Nyvepria was approved for medical use in the European Union in November 2020. Nyvepria was approved for medical use in Canada in October 2020. Stimufend was approved for medical use in the European Union in March 2022. Pegfilgrastim-pbbk (Fylnetra) was approved for medical use in the United States in May 2022. Pegfilgrastim-fpgk (Stimufend) was approved for medical use in the United States in September 2022.

References

External links

* * {{Portal bar , Medicine Immunostimulants Recombinant proteins Amgen Hoffmann-La Roche brands