EC approves Sandoz’s biosimilar Ziextenzo for febrile neutropenia

Novartis unit Sandoz has received marketing authorisation from the European Commission (EC) for biosimilar Ziextenzo (pegfilgrastim).

Ziextenzo is intended to cut down the duration of neutropenia and incidence of febrile neutropenia in adult patients undergoing cytotoxic (anti-cancer) chemotherapy for malignancy, with the exception being chronic myeloid leukemia and myelodysplastic syndromes.

Sandoz global head of biopharmaceuticals Stefan Hendriks said: "Despite advancements in cancer treatment, febrile neutropenia remains one of the most significant complications of chemotherapy and is a major cause of morbidity.

"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."

This approval comes on the basis of analytical, preclinical and clinical data. These studies showed that Ziextenzo matched the reference medicine in terms of safety, efficacy and quality aspects.

An active substance in Ziextenzo called pegfilgrastim is a long-acting form of filgrastim, which boosts white blood cell production.

Filgrastim is very similar to natural protein granulocyte-colony stimulating factor, also called G-CSF, produced by the body.

It may be used to cut down the duration of neutropenia, which is low white blood cell count, and the occurrence of febrile neutropenia, which is low white blood cell count along with fever. Febrile neutropenia is caused due to cytotoxic chemotherapy.

Sandoz has eight approved biosimilars worldwide, including five in the last 18 months.

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