Sandoz receives US FDA approval for long-acting oncology supportive care biosimilar Ziextenzo™ (pegfilgrastim-bmez)

  • Ziextenzo™ is indicated to decrease the incidence of febrile neutropenia, one of the most serious side effects of chemotherapy 
  • With approval of Ziextenzo , Sandoz is first and only company to offer US physicians long- and short-acting filgrastim biosimilar treatment options
  • With four US approved biosimilars, Sandoz is committed to expanding patient access, increasing healthcare savings and fueling innovation

HOLZKIRCHEN, Germany I November 5, 2019 I Sandoz, a Novartis division and a global leader in biosimilars, today announced that the US Food and Drug Administration (FDA) approved its biosimilar ZiextenzoTM (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

Please see full Prescribing Information for Ziextenzo here.

About Sandoz
Sandoz, a Novartis division, is a global leader in generic pharmaceuticals and biosimilars. Our purpose is to pioneer access for patients by developing and commercializing novel, affordable approaches that address unmet medical need. Our ambition is to be the world’s leading and most valued generics company. Our broad portfolio of high-quality medicines, covering all major therapeutic areas, accounted for 2018 sales of USD 9.9 billion. Sandoz is headquartered in Holzkirchen, in Germany's Greater Munich area.

Sandoz is on Twitter. Sign up to follow @Sandoz global at http://twitter.com/Sandoz_Global

References

  1. V Caggiano, RV Weiss, TS Rickert, et al. Incidence, cost, and mortality of neutropenia hospitalization associated with chemotherapy. Cancer. Volume 103. Pages 1916-1924. May 1, 2005. Available at: https://www.ncbi.nlm.nih.gov/pubmed/15751024. Accessed August 27, 2019.
  2. R Nakov, S Schussler, S Schier-Mumzhiu, et. al. A large multi-center, randomized, double-blind, crossover study in healthy volunteers to compare pharmacokinetics and pharmacodynamics of a proposed biosimilar pegfilgrastim with EU and US reference pegfilgrastim: Methodological approach. Annals of Oncology, Volume 29, Issue suppl_8, 1 October 2018, mdy300.110.
  3. Wang W, Balu S, Campbell K. Cost-minimization analysis for biosimilar pegfilgrastim in the prophylaxis of chemotherapy induced (febrile) neutropenia and expanded access based on budget neutral basis. Data presented at 2019 ASCO Annual Meeting
  4. Ziextenzo. Prescribing Information. Available at: https://www.us.sandoz.com/sites/www.us.sandoz.com/files/Ziextenzo_PI_2019.pdf. Accessed November 5, 2019.
  5. European Medicines Agency. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/ziextenzo#product-information-section. Accessed August 27, 2019.

SOURCE: Sandoz

La Merie Biologics

FREE Weekly News Bulletin

Sign Up

2018 Sales ofAntibodies & Proteins

New Product Alert

For La Merie Publishing

Sign Up

Top