, Volume 33, Issue 2, pp 229–232 | Cite as

LA-EP2006: A Pegfilgrastim Biosimilar

  • Sheridan M. HoyEmail author
Adis Biosimilar Brief


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.


Compliance with Ethical Standards


The preparation of this review was not supported by any external funding. During the peer review process, the manufacturer of LA-EP2006 was also offered an opportunity to review this article. Changes resulting from comments received were made on the basis of scientific and editorial merit. Sheridan Hoy is a salaried employee of Adis/Springer, is responsible for the article content and declares no relevant conflicts of interest.


  1. 1.
    Sandoz GmbH. Ziextenzo 6 mg solution for injection in pre-filled syringe: EU summary of product characteristics. 2019. Accessed 17 Jan 2019.
  2. 2.
    European Medicines Agency. Ziextenzo (pegfilgrastim): EU assessment report. 2019. Accessed 24 Jan 2019.
  3. 3.
    Nakov R, Gattu S, Wang J, et al. Proposed biosimilar pegfilgrastim shows similarity in pharmacokinetics and pharmacodynamics to reference pegfilgrastim in healthy subjects. Br J Clin Pharmacol. 2018;84(12):2790–801.CrossRefGoogle Scholar
  4. 4.
    Data on file, Sandoz, 2019.Google Scholar
  5. 5.
    Nakov R, Schussler S, Schier-Mumzhiu S, et al. A large multi-center, randomized, double-blind, crossover study in healthy volunteers to compare pharmacokinetics and pharmacodynamics of a proposed biosimilar pegfilgrastim with EU and US reference pegfilgrastim: methodological approach [abstract no. 1796P]. Ann Oncol. 2018;29(Suppl 8).Google Scholar
  6. 6.
    Harbeck N, Lipatov O, Frolova M, et al. Randomized, double-blind study comparing proposed biosimilar LA-EP2006 with reference pegfilgrastim in breast cancer. Future Oncol. 2016;12(11):1359–67.CrossRefGoogle Scholar
  7. 7.
    Blackwell K, Donskih R, Jones CM, et al. A comparison of proposed biosimilar LA-EP2006 and reference pegfilgrastim for the prevention of neutropenia in patients with early-stage breast cancer receiving myelosuppressive adjuvant or neoadjuvant chemotherapy: pegfilgrastim randomized oncology (supportive care) trial to evaluate comparative treatment (PROTECT-2), a phase III, randomized, double-blind trial. Oncologist. 2016;21(7):789–94.CrossRefGoogle Scholar
  8. 8.
    Blackwell K, Gascon P, Jones CM, et al. Pooled analysis of two randomized, double-blind trials comparing proposed biosimilar LA-EP2006 with reference pegfilgrastim in breast cancer. Ann Oncol. 2017;28(9):2272–7.CrossRefGoogle Scholar
  9. 9.
    Harbeck N, Gascon P, Jones CM, et al. Proposed biosimilar pegfilgrastim (LA-EP2006) compared with reference pegfilgrastim in Asian patients with breast cancer: an exploratory comparison from two phase III trials. Future Oncol. 2017;13(16):1385–93.CrossRefGoogle Scholar
  10. 10.
    Bennett CL, Chen B, Hermanson T, et al. Regulatory and clinical considerations for biosimilar oncology drugs. Lancet Oncol. 2014;15(13):e594–605.CrossRefGoogle Scholar

Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  1. 1.SpringerAucklandNew Zealand

Personalised recommendations