Sandoz receives US FDA approval for long-acting oncology supportive care biosimilar Ziextenzo (pegfilgrastim-bmez)
[caption id="attachment_9277" align="aligncenter" width="747"] Press Release[/caption]
- Ziextenzo??is indicated to decrease the incidence of febrile neutropenia, one of the most serious side effects of chemotherapy ?
- With approval of Ziextenzo??, Sandoz is first and only company to offer US physicians long- and short-acting filgrastim biosimilar treatment options
- With four US approved biosimilars, Sandoz is committed to expanding patient access, increasing healthcare savings and fueling innovation
- V Caggiano, RV Weiss, TS Rickert, et al. Incidence, cost, and mortality of neutropenia hospitalization associated with chemotherapy. Cancer. Volume 103. Pages 1916-1924. May 1, 2005. Available at:?https://www.ncbi.nlm.nih.gov/pubmed/15751024. Accessed August 27, 2019.
- R Nakov, S Schussler, S Schier-Mumzhiu, 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. Annals of Oncology, Volume 29, Issue suppl_8, 1 October 2018, mdy300.110.
- Wang W, Balu S, Campbell K. Cost-minimization analysis for biosimilar pegfilgrastim in the prophylaxis of chemotherapy induced (febrile) neutropenia and expanded access based on budget neutral basis. Data presented at 2019 ASCO Annual Meeting
- Ziextenzo. Prescribing Information. Available at:?https://www.us.sandoz.com/sites/www.us.sandoz.com/files/Ziextenzo_PI_2019.pdf. Accessed November 5, 2019.
- European Medicines Agency. Available at:?https://www.ema.europa.eu/en/medicines/human/EPAR/ziextenzo#product-information-section. Accessed August 27, 2019.