Sandoz receives FDA approval for oncology long-acting supportive care biosimilar

Listen to this article

Princeton-based Sandoz, a Novartis division, announced on Tuesday that the U.S. Food and Drug Administration approved its biosimilar Ziextenzo (pegfilgrastim-bmez).

Approved and marketed in Europe as Ziextenzo (pegfilgrastim) since 2018, Sandoz now intends to launch Ziextenzo in the U.S. by the end of the year.

Ziextenzo 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.

“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.

“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 U.S. – including consistent product supply and reliable patient services,” Lynch said.

According to Sandoz, a study has shown that each year in the U.S., more than 60,000 cancer patients are hospitalized with evidence of neutropenia, including fever or infection, with more than 4,000 deaths as a result.

Sandoz said that it is now the first and only company to offer physicians in the U.S. 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.

The FDA approval of Ziextenzo was based on analytical, preclinical and clinical research, including data from a pivotal three-way pharmacokinetics (PK) and pharmacodynamics (PD) study (LA-EP06-104).

This study compared Sandoz pegfilgrastim with U.S.-sourced reference pegfilgrastim, Sandoz pegfilgrastim with EU-sourced reference pegfilgrastim, and U.S.-sourced with EU-sourced reference pegfilgrastim. PK and PD similarity were demonstrated in all three comparisons, and no clinically meaningful differences were observed regarding safety and immunogenicity among the treatment groups.