The US Food and Drug Administration (FDA) has approved Sandoz’ biosimilar Ziextenzo (pegfilgrastim-bmez). The biosimilar pegfilgrastim has been approved and marketed in Europe as Ziextenzo (pegfilgrastim) since 2018, and now Sandoz intends to launch Ziextenzo in the US as soon as possible this year.

The drug is indicated to decrease the incidence of infection, as manifested by febrile neutropenia (low white blood cell count with a fever), in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

The Novartis division revealed that the the FDA approval was based on analytical, preclinical and clinical research, including data from a pivotal three-way pharmacokinetics (PK) and pharmacodynamics (PD) study. In the study, Sandoz pegfilgrastim and US-sourced reference pegfilgrastim were compared with Sandoz pegfilgrastim with EU-sourced reference pegfilgrastim, and US-sourced with EU-sourced reference pegfilgrastim.

The trial found that similarity was demonstrated in all three comparisons, and no clinically meaningful differences were observed regarding safety and immunogenicity among the treatment groups.

“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.

She continued, “The approval of Ziextenzo expands our oncology portfolio, providing physicians with a long-acting supportive oncology biosimilar option. It builds on the foundation of trust and experience we developed with our short-acting filgrastim Zarxio – the leading filgrastim by market share in the US – including consistent product supply and reliable patient services.”

Each year in the US, more than 60,000 cancer patients are hospitalised with evidence of neutropenia, including fever or infection, with more than 4,000 deaths as a result. As of the approval, Sandoz is now the first and only company to offer physicians in the US the choice between a long- and short-acting biosimilar filgrastim treatment to best suit the individual needs of tens of thousands of patients undergoing chemotherapy.