FDA Approves Ziextenzo (pegfilgrastim-bmez), a Biosimilar to Neulasta
Holzkirchen, Nov. 5, 2019 – Sandoz, a Novartis division and a global leader in biosimilars, today announced that the US Food and Drug Administration (FDA) approved its biosimilar Ziextenzo (pegfilgrastim-bmez). Sandoz biosimilar pegfilgrastim has been approved and marketed in Europe as Ziextenzo® (pegfilgrastim) since 2018. Sandoz now intends to launch Ziextenzo in the US as soon as possible this 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. “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.”
A study has shown that each year in the US, 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.1 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.
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).2 This study compared Sandoz pegfilgrastim with US-sourced reference pegfilgrastim, Sandoz pegfilgrastim with EU-sourced reference pegfilgrastim, and US-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.
Sandoz has proven biosimilars create early and expanded patient access to life-changing biologics while increasing healthcare savings. Its four approved biosimilars in the US are part of a leading global portfolio with eight marketed biosimilars. Building on this success, Ziextenzo can help increase positive treatment outcomes for patients undergoing chemotherapy and drive significant savings for the healthcare system.2,3
Sandoz is a global biosimilar leader and will continue to help millions of patients in oncology, immunology, endocrinology and other underserved therapy areas access biologic medicines sustainably and affordably.
About Ziextenzo (pegfilgrastim-bmez)
Pegfilgrastim is a long-acting form of filgrastim. Filgrastim is very similar to a natural protein (granulocyte-colony stimulating factor) – also known as G-CSF – produced by a person's own body. Ziextenzo is indicated in the US 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.4 Febrile neutropenia is caused by cytotoxic chemotherapy (medicines that destroy rapidly growing cells); white blood cells are important as they help your body fight infection.5 (Article from : www.drugs.com)