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Confirmed Biosimilarity▾  |  PK/PD Switch Study▾  |  Confirmatory Trials

The efficacy and safety profile you've come to expect

ZIEXTENZO demonstrated biosimilarity to its reference product via a rigorous preclinical and clinical program.1-3

ZIEXTENZO offers the same efficacy and safety profile as Neulasta®1,2,4

PK/PD

  • ZIEXTENZO demonstrated PK and PD similarity vs Neulasta® US and Neulasta® EU4
  • The 90% CIs of these parameters were within the predefined equivalence margins of 0.80-1.254
ZIEXTENZO compares similarly to Neulasta in PK/PD, Safety, Immunogenicity, and MOA.

Safety

  • The safety profile of ZIEXTENZO matched that of Neulasta® US and Neulasta® EU1,2a
  • The overall incidence of TEAEs was similar as well1,2
ZIEXTENZO compares similarly to Neulasta in PK/PD, Safety, Immunogenicity, and MOA.

Immunogenicity

  • Incidence of ADAs was low and similar to Neulasta® US and Neulasta® EU1,2b
ZIEXTENZO compares similarly to Neulasta in PK/PD, Safety, Immunogenicity, and MOA.

MOA

  • ZIEXTENZO is a recombinant G-CSF that acts on hematopoietic cells by binding to specific cell surface receptors, identical to Neulasta®5,6
ZIEXTENZO compares similarly to Neulasta in PK/PD, Safety, Immunogenicity, and MOA.

aNo clinically meaningful differences were observed regarding safety and local tolerance among the treatment groups.4
b
ADAs had no impact on PK, PD, or safety.4

Biosimilarity confirmed through totality of evidence7

Clinical: 2 confirmatory safety and efficacy phase 3 studies. PK/PD: Human PK and PD equivalence studies. Nonclinical: Animal PK,PD and toxicity studies. Analytical Foundation for Biosimilar Approval: Structural and functional characterization.

ZIEXTENZO went through extensive preclinical characterization to Neulasta®9

  • State-of-the-art technology comparing key structural and functional attributes, including primary structure, higher order structure, pegylation, purity, aggregates, bioactivity, and receptor binding7
  • >40 different methodologies used to analyze >100 different specifications to demonstrate sameness10-12

 

Efficacy shown in ZIEXTENZO vs Neulasta® PK/PD crossover study in healthy subjects4

  • The primary objectives of the study were met: PK and PD similarity were demonstrated between ZIEXTENZO and Neulasta® US and between ZIEXTENZO and Neulasta® EU4

The LA-EP06-104 study was designed to demonstrate similarity between ZIEXTENZO and Neulasta®4

LA- EP06- 104 Study Design comparing ZIEXTENZO, Neulasta Us, and Neulasta EU over 3 treatment periods.

The LA-EP06-104 study proved bioequivalency to Neulasta®4

Mean (SD) pegfilgrastim serum concentration-time profiles overall (full analysis set for PK)

LA-EP06-104 Bioequivalency to Neulasta

ZIEXTENZO: The only biosimilar pegfilgrastim with 2 confirmatory phase 3 trials1,2,13-15

Table comparing ZIEXTENZO to Neulasta in PROTECT -1 and PROTECT – 2.

PROTECT-1 and PROTECT-2 were global, prospective, randomized, multicenter, double-blind, head-to-head, phase 3 confirmatory trials designed to demonstrate the efficacy and safety equivalence of ZIEXTENZO to Neulasta®* in patients with breast cancer receiving myelosuppressive chemotherapy (PROTECT-1, N=316; PROTECT-2, N=308).1,2

*Neulasta® EU and Neulasta® US were the reference pegfilgrastim in PROTECT-1 and PROTECT-2, respectively.1,2

ADA=anti-drug antibody; ANC=absolute neutrophil count; AUC0-inf=area under the serum concentration time curve measured from the time of dosing to infinity; AUC0-last=area under the serum concentration time curve measured from the time of dosing to the last measurable concentration; AUEC0-last=area under the effect curve measured from the time of dosing to the last measurable concentration; CI=confidence interval; Cmax=maximum observed serum concentration; Emax=maximum effect attributable to the Investigational Medicinal Product; G-CSF=granulocyte colony-stimulating factor; MOA=mechanism of action; PD=pharmacodynamic; PK=pharmacokinetic; SD=standard deviation; TEAE=treatment-emergent adverse event.

Neulasta is a registered trademark of Amgen Inc.

References: 1. 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):1359-1367. 2. Blackwell K, Donskih R, Jones MC, 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):789-794. 3. Data on file. Investigator's Brochure. Sandoz Inc. June 2018. 4. Data on file. Clinical Study Report of Study LA-EP06-104. Sandoz Inc. February 2019. 5. ZIEXTENZO Prescribing Information. Sandoz Inc. September 2020. 6. Neulasta Prescribing Information. Amgen Inc. January 2020. 7. US Department of Health and Human Services. Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Guidance for Industry. Washington, DC: US Dept of Health and Human Services; April 2015. 8. US Food and Drug Administration. Presented at: FDA Oncologic Drugs Advisory Committee Meeting; January 7, 2015. 9. Hoy SM. LA-EP2006: a pegfilgrastim biosimilar. BioDrugs. 2019;33(2):229-232. 10. McCamish M, Woollett G. The state of the art in the development of biosimilars. Clin Pharmacol Ther. 2012;91(3):405-417. 11. Vandekerckhove K, Seidl A, Gutka H, et al. Rational selection, criticality assessment, and tiering of quality attributes and test methods for analytical similarity evaluation of biosimilars. AAPS J. 2018;20(4):68. doi:10.1208/s12248-018-0230-9. 12. Data on file. Specification Methods. Sandoz Inc. February 2020. 13. Fulphila Prescribing Information. Mylan GmbH. June 2020. 14. Udenyca Prescribing Information. Coherus BioSciences Inc. September 2019. 15. Waller CF, Ranganna GM, Pennella EJ, et al. Randomized phase 3 efficacy and safety trial of proposed pergfilgrastim biosimilar MYL 1401H in the prophylactic treatment of chemotherapy-induced neutropenia. Ann Hematol. 2019;98(5):1217-1224.