EMA CHMP 对 Neuzafy（非格司亭）生物类似药给出积极意见

Overview

On 15 October 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Neuzafy, intended for the treatment of neutropenia and the mobilisation of peripheral blood progenitor cells (PBPCs).

The applicant for this medicinal product is CuraTeQ Biologics (Malta) Limited.

Neuzafy will be available as 30 MU/0.5 ml and 48 MU/0.5 ml solution for injection/infusion. The active substance of Neuzafy is filgrastim, an immunostimulant, colony stimulating factor (ATC code:L03AA02). Filgrastim is a recombinant granulocyte colony-stimulating factor (G-CSF), a type of haematopoietic growth factor. By binding to the G-CSF receptor, filgrastim stimulates the production and differentiation of mature and functionally active neutrophils from bone marrow precursor cells.

Neuzafy is a biosimilar medicinal product. It is highly similar to the reference product Neupogen (filgrastim), which has been authorised in various EU countries. Data show that Neuzafy has comparable quality, safety and efficacy to Neupogen (filgrastim).

The full indication is:

Neuzafy is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia. 

The safety and efficacy of Neuzafy are similar in adults and children receiving cytotoxic chemotherapy. 

Neuzafy is indicated for the mobilisation of peripheral blood progenitor cells (PBPCs). 

In patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of ≤ 0.5 x 10⁹/L, and a history of severe or recurrent infections, long term administration of Neuzafy is indicated to increase neutrophil counts and to reduce the incidence and duration of infection‑related events.

Neuzafy is indicated for the treatment of persistent neutropenia (ANC less than or equal to 1 x 10⁹/L) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.

Neuzafy should be prescribed and given by physicians experienced in oncology and haematology.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after the marketing authorisation has been granted by the European Commission.

Product details

Name of medicine

Neuzafy

Active substance

filgrastim

International non-proprietary name (INN) or common name

filgrastim

Therapeutic area (MeSH)

• Neutropenia
• Febrile Neutropenia
• Chemotherapy-Induced Febrile Neutropenia

Anatomical therapeutic chemical (ATC) code

L03AA02

EMA product number

EMEA/H/C/007009

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.

Marketing authorisation applicant

CuraTeQ Biologics (Malta) Limited

Opinion adopted

15/10/2026

Opinion status

Positive