Ziextenzo

pegfilgrastim

Opinion

On 20 September 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Ziextenzo, intended to reduce the duration of neutropenia and the incidence of febrile neutropenia due to chemotherapy. The applicant for this medicinal product is Sandoz GmbH.

Ziextenzo will be available as a 6-mg solution for injection. The active substance of Ziextenzo is pegfilgrastim, an immunostimulant (ATC code: L03AA13) that belongs to the class of haematopoietic growth factors (granulocyte-colony stimulating factor; G-CSF) which increase the production and differentiation of mature and functionally active neutrophils from bone marrow precursor cells.

Ziextenzo is a biosimilar medicinal product. It is highly similar to the reference product Neulasta (pegfilgrastim), which was authorised in the EU on 22 August 2002. Data show that Ziextenzo has comparable quality, safety and efficacy to Neulasta. 

The full indication is: “Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).” It is proposed that Ziextenzo be initiated and supervised by physicians experienced in oncology and/or haematology.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

Key facts

Name
Ziextenzo
International non-proprietary name (INN) or common name
  • pegfilgrastim
Active substance
  • pegfilgrastim
Therapeutic area
Neutropenia
Biosimilar

This is a biosimilar medicine, which is a biological medicine highly similar to another already approved biological medicine called the ‘reference medicine’. For more information, see Biosimilar medicines.

Date opinion adopted
20/09/2018
Company name
Sandoz GmbH
Status
Positive
Application type
Initial authorisation

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