Sandoz, a biosimilars division of Novartis, has received the US Food and Drug Administration (FDA) approval for the biosimilar Ziextenzo (pegfilgrastim-bmez).

Sandoz has been marketing its biosimilar pegfilgrastim in Europe as Ziextenzo since 2018, and is planning to roll out Ziextenzo in the US this year.

Sandoz president Carol Lynch said: “When a cancer patient with febrile neutropenia gets an infection, it can have serious consequences such as delays or dose reductions of chemotherapy. 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.”

FDA has approved Ziextenzo based on preclinical and clinical research

Pegfilgrastim is a long-acting form of filgrastim, which is very similar to a natural protein granulocyte-colony stimulating factor (G-CSF), produced inside the human body.

Sandoz’s biosimilar is indicated to decrease the incidence of infection, characterised by reduced white blood cell count accompanied by fever, called febrile neutropenia. Neutropenia is caused by cytotoxic chemotherapy, where medicines destroy the rapidly growing cells.

Ziextenzo is approved for treating patients with non-myeloid malignancies, under myelosuppressive anti-cancer drugs, and with the incidence of febrile neutropenia.

The company said that the FDA has approved Ziextenzo based on analytical, preclinical and clinical research, including data from a three-way pharmacokinetics (PK) and pharmacodynamics (PD) study.

The study individually compared Sandoz pegfilgrastim with US-sourced reference pegfilgrastim and EU-sourced reference pegfilgrastim. It also compared the US-sourced pegfilgrastim with EU-sourced reference pegfilgrastim.

In addition, all three comparisons have demonstrated the similarity between PK and PD, and no clinically meaningful differences related to safety and immunogenicity was observed in the study.

Sandoz claims that it is the first and only company to offer a long-acting biosimilar along with a short-acting biosimilar filgrastim treatment in the US.