Novartis’ Sandoz unit has secured approval for Ziextenzo (pegfilgrastim-bmez), a biosimilar to Amgen’s Neulasta (pegfilgrastim) from the US Food and Drug Administration (FDA).
Ziextenzo, like its reference drug pegfilgrastim, has been indicated to reduce the chances of infection caused by low white blood cell count with a fever – a condition called febrile neutropenia.
Pegfilgrastim is a long-acting form of filgrastim, which is said to be very identical to a natural protein – granulocyte-colony stimulating factor. Also called G-CSF, the protein is generated by a person’s own body.
The biosimilar has been approved to be used in patients having non-myeloid malignancies who are undergoing treatment with myelosuppressive anti-cancer drugs known for causing febrile neutropenia incidents as side effects.
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.”
In Europe, the Sandoz biosimilar was approved last year and has been marketed as Ziextenzo.
Its approval in the US has been granted based on data from a three-way pharmacokinetics (PK) and pharmacodynamics (PD) study, and other analytical, preclinical and clinical research.
According to Novartis, the three-way study evaluated the Sandoz biosimilar with US-sourced reference pegfilgrastim, with EU-sourced reference pegfilgrastim, and US-sourced with EU-sourced reference pegfilgrastim.
In all the three comparisons, PK and PD similarity were shown with no clinically meaningful differences on the safety and immunogenicity observed among the treatment arms, said the Swiss drugmaker.
Sandoz expects to launch Ziextenzo in the US as soon as possible in the current year.
The pegfilgrastim biosimilar from Sandoz was rejected by the FDA in 2016. In April 2019, Sandoz resubmitted the drug’s biologics license application (BLA) to the FDA after addressing concerns raised by the regulator during the rejection.