Pegfilgrastim

Pegfilgrastim is a PEGylated form of the recombinant human granulocyte colony-stimulating factor (GCSF) analog filgrastim. It serves to stimulate the production of white blood cells (neutrophils).[2]

Pegfilgrastim
Clinical data
Trade namesoriginally Neulasta, other brand names worldwide[1]
AHFS/Drugs.comMonograph
MedlinePlusa607058
License data
Pregnancy
category
  • US: C (Risk not ruled out)
    ATC code
    Legal status
    Legal status
    Pharmacokinetic data
    Elimination half-life15–80 hrs
    Identifiers
    CAS Number
    IUPHAR/BPS
    DrugBank
    ChemSpider
    • none
    UNII
    KEGG
    ChEMBL
    ECHA InfoCard100.169.155
    Chemical and physical data
    FormulaC845H1343N223O243S9 + PEG
    Molar mass39,000 g/mol g·mol−1
     NY (what is this?)  (verify)

    Pegfilgrastim treatment can be used to stimulate bone marrow to produce more neutrophils to fight infection in patients undergoing chemotherapy.[3]

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

    In the United States as of 2015 the branded form costs between $5,327 and $8,191 a dose.[5]

    As of 22 September 2015 a 6 mg/0.6 ml dose costs $15,016.29 in the United States.

    Biosimilars

    In July 2016 the US FDA rejected a biosimilar application from Sandoz.[6]

    On November 2, 2018 Coherus Biosciences received FDA approval for its biosimilar, 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.[7]

    References
    1. Drugs.com International brand names for pegfilgrastim Page accessed April 1, 2016
    2. Walsh, G, Spada, S. "Epogen/Procrit" in: Directory of approved biopharmaceutical products. CRC Press, 2005, pp. 136–37.
    3. Drugs.com: Pegfilgrastim
    4. Ho, R.J.Y., Gibaldi, M. Biotechnology and biopharmaceuticals: transforming proteins and genes into drugs Wiley-IEEE, 2003, pp. 139, 158.
    5. Langreth, Robert (June 29, 2016). "Decoding Big Pharma's Secret Drug Pricing Practices". Bloomberg. Retrieved 15 July 2016.
    6. US FDA rejects Sandoz’s Neulasta biosimilar. 19 July 2016
    7. "FDA Approves Coherus' Pegfilgrastim Biosimilar, Udenyca".


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