LA-EP2006: A Pegfilgrastim Biosimilar.

Abstract

LA-EP2006 (Ziextenzo®) is the fifth biosimilar of pegfilgrastim, a pegylated recombinant granulocyte colony-stimulating factor, to be approved in the EU. It is approved for use in adults treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) to reduce the duration of neutropenia and the incidence of febrile neutropenia. LA-EP2006 matched reference pegfilgrastim in terms of physicochemical characteristics and functional properties, and the pharmacodynamic and pharmacokinetic similarity of the medicines has been shown in healthy volunteers. LA-EP2006 demonstrated clinical efficacy equivalent to that of EU-sourced reference pegfilgrastim in adult women with breast cancer receiving chemotherapy. The tolerability and safety profile of and the incidence of anti-drug antibodies with LA-EP2006 were similar to those of EU-sourced reference pegfilgrastim in this patient population. The role of reference pegfilgrastim in the management of chemotherapy-induced neutropenia is well established and LA-EP2006 provides an effective biosimilar alternative for patients requiring pegfilgrastim therapy.

• Authors: Sheridan M Hoy
• Journal: BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy (BioDrugs) Vol. 33 Issue 2 Pg. 229-232 (Apr 2019) ISSN: 1179-190X [Electronic] New Zealand
• PMID: 30887256 (Publication Type: Journal Article, Review)

Chemical References

• Biosimilar Pharmaceuticals
• pegfilgrastim
• Polyethylene Glycols
• Filgrastim

Topics

• Adult
• Biosimilar Pharmaceuticals (adverse effects, pharmacokinetics, therapeutic use)
• Breast Neoplasms (drug therapy)
• Double-Blind Method
• Female
• Filgrastim (adverse effects, pharmacokinetics, therapeutic use)
• Humans
• Neutropenia (chemically induced)
• Polyethylene Glycols (adverse effects, pharmacokinetics, therapeutic use)
• Randomized Controlled Trials as Topic
• Therapeutic Equivalency