The FDA has approved Ziextenzo (pegfilgrastim-bmez), Sandoz’s biosimilar pegfilgrastim referencing Neulasta. The biosimilar was approved to decrease the incidence of infection, as manifested by febrile neutropenia, in patients receiving myelosuppressive anticancer treatment. Sandoz plans to launch the product this year.
The FDA has approved Ziextenzo (pegfilgrastim-bmez), Sandoz’s biosimilar pegfilgrastim referencing Neulasta. The biosimilar was approved to decrease the incidence of infection, as manifested by febrile neutropenia, in patients receiving myelosuppressive anticancer treatment. Sandoz plans to launch the product this year.
“When a cancer patient with febrile neutropenia gets an infection, it can have serious consequences such as delays or dose reductions of chemotherapy,” said Carol Lynch, president of Sandoz Inc, in a statement announcing the regulatory decision. “The approval of Ziextenzo expands our oncology portfolio, providing physicians with a long-acting supportive oncology biosimilar option.”
The approval comes at the end of a long regulatory road for Sandoz; in 2016, Sandoz received a Complete Response Letter for the biosimilar, and in order to address the agency’s concerns, the biosimilar developer provided new data from a pivotal pharmacokinetic (PK) and pharmacodynamic (PD) study.
The study was a single-dose, 3-period crossover study that compared the biosimilar with the US-sourced and EU-sourced reference pegfilgrastim, and it compared the US and EU references.1 The study sought to address the high inter-subject variability (ISV) linked to target-mediated clearance with pegfilgrastim; the 3-way crossover design was intended to address ISV and to provide a bridge between the EU and US reference pegfilgrastim products.
A previous PK study was conducted in healthy volunteers, and the biosimilar has also been studied in phase 3 clinical trials (PROTECT-1 and PROTECT-2) in patients undergoing chemotherapy.2
In a combined analysis of the safety of the biosimilar across those trials, researchers reported that there were no differences in adverse events (AEs) reported by patients receiving the biosimilar or the reference pegfilgrastim in the phase 3 studies. Differences in AEs reported by those enrolled in the phase 1 versus the phase 3 studies, they concluded, were likely related to differences in baseline health status, sex differences, and other patient factors.
The biosimilar is also approved in the European Union, where it received a marketing authorization from the European Commission in November 2018.
Ziextenzo joins 2 other approved biosimilar pegfilgrastim products in the United States: Mylan and Biocon’s Fulphila, and Coherus BioSciences’ Udenyca, both of which have launched in the US market. The approval also makes Sandoz the first biosimilar maker to have both a short-acting granulocyte colony-stimulating factor biosimilar (Zarxio) and a long-acting biosimilar option approved.
References
1. 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. Ann Oncol. 2018;29(8)mdy300.110. doi: 10.1093/annonc/mdy300.110.
2. Harbeck N, Wang J, Otto GP, Gattu S, Krendyukov A. Safety analysis of proposed pegfilgrastim biosimilar in phase I and phase III studies [published online March 5, 2019]. Future Oncol. doi: 10.2217/fon-2018-0878.
BioRationality: EMA Accepts Waiver of Clinical Efficacy Testing of Biosimilars
April 21st 2025Sarfaraz K. Niazi, PhD, shares his latest citizen's petition to the FDA, calling on the agency to waive clinical efficacy testing in response to the European Medicines Agency's (EMA) efforts towards the same goal.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
President Trump Signs Executive Order to Bring Down Drug Prices
April 16th 2025To help bring down sky-high drug prices, President Donald Trump signed an executive order pushing for faster biosimilar development, more transparency, and tougher rules on pharmacy benefit managers—aiming to save billions and make meds more affordable for everyone.
Biosimilars Oncology Roundup for June 2024—Podcast Edition
July 7th 2024On this episode of Not So Different, we review biosimilar news coming out of June, with clinical trial results from conferences and a study showcasing how to overcome economic and noneconomic barriers to oncology biosimilars.
Latest Biosimilar Deals Signal Growth Across Immunology, Oncology Markets
April 14th 2025During Q1 2025, pharmaceutical companies accelerated biosimilar expansion through strategic acquisitions and partnerships in hopes of boosting patient access to lower-cost treatments in immunology and oncology.
Experts Pressure Congress to Remove Roadblocks for Biosimilars
April 12th 2025Lawmakers and expert witnesses emphasized the potential of biosimilars to lower health care costs by overcoming barriers like pharmacy benefit manager practices, limited awareness, and regulatory delays to improve access and competition in chronic disease management during a recent congressional hearing.