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Pegfilgrastim Biosimilar Approved in Europe

Gina Columbus @ginacolumbusonc
Published: Tuesday, Nov 27, 2018

Paul Cornes, MD

Paul Cornes, MD

The European Commission has granted approval to the biosimilar Ziextenzo (LA-EP2006), a biosimilar for pegfilgrastim (Neulasta), as a treatment to reduce the duration of neutropenia and incidence of febrile neutropenia that is associated with anticancer chemotherapy, according to Sandoz, the developer of the agent.1

"Despite advancements in cancer treatment, febrile neutropenia remains one of the most significant complications of chemotherapy and is a major cause of morbidity," Stefan Hendriks, global head, Biopharmaceuticals, Sandoz, said in the press release. "With the approval of Ziextenzo, a long-acting version of oncology supportive medicine filgrastim, we look forward to providing a treatment option that delivers the possibility of further reducing both the personal and financial burden of cancer."

References

  1. Sandoz receives eighth European Commission approval for a biosimilar with Ziextenzo® (pegfilgrastim). Novartis. Published November 27, 2018. Accessed November 27, 2018. https://bit.ly/2TK7Tuu.
  2. Nakov R, Gattu S, Wang J, et al. Proposed biosimilar pegfilgrastim shows similarity in pharmacokinetics and pharmacodynamics to reference pegfilgrastim in healthy subjects [published online August 5, 2018]. Br J Clin Pharmacol. doi: 10.1111/bcp.13731.

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Medical Crossfire®: Addressing Uncertainties in Oncology BiosimilarsApr 30, 20201.5
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