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EMA Recommends Granting a Marketing Authorisation for Stimufend

Stimufend is a biosimilar, highly similar to the reference product Neulasta (pegfilgrastim), which was authorised in the EU in 2002
02 Mar 2022
Palliative and supportive care

On 27 January 2022, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product pegfilgrastim (Stimufend), intended to reduce the duration of neutropenia and the incidence of febrile neutropenia after cytotoxic chemotherapy.

The applicant for this medicinal product is Fresenius Kabi Deutschland GmbH.

Stimufend will be available as a 6 mg solution for injection. The active substance of Stimufend is pegfilgrastim, an immunostimulant and colony stimulating factor (ATC code: L03AA13) which stimulates the production and differentiation of mature and functionally active neutrophils from bone marrow precursor cells.

Stimufend 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 Stimufend has comparable quality, safety and efficacy to Neulasta (pegfilgrastim).

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.

Stimufend therapy should 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, which will be published in the European public assessment report and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

Summaries of positive opinion are published without prejudice to the Commission decision, which will normally be issued 67 days from adoption of the opinion.

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