ZIEXTENZO demonstrated biosimilarity to its reference product via a rigorous preclinical and clinical program.1-3
ZIEXTENZO went through extensive preclinical characterization to Neulasta9
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. November 2019. 6. Neulasta Prescribing Information. Amgen Inc. April 2019. 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. Data on file. State-of-the-art manufacturing and quality. Sandoz Inc. 11. Fulphila Prescribing Information. Mylan GmbH. May 2019. 12. Udenyca Prescribing Information. Coherus BioSciences Inc. September 2019. 13. Waller CF, Ranganna GM, Pennella EJ, et al. Randomized phase 3 efficacy and safety trial of proposed pegfilgrastim biosimilar MYL-1401H in the prophylactic treatment of chemotherapy-induced neutropenia. Ann Hematol. 2019;98(5):1217-1224.