What happened?
On 15 October 2026 the EMA’s CHMP issued a positive opinion recommending marketing authorisation for Neuzafy, a filgrastim biosimilar from CuraTeQ Biologics (Malta) Limited. Neuzafy is presented as injectable solution (30 MU/0.5 ml and 48 MU/0.5 ml) and is intended for indications including chemotherapy‑induced neutropenia and PBPC mobilisation in adults and children.
Why does it matter?
Filgrastim stimulates neutrophil production and is used to reduce duration of neutropenia and febrile neutropenia in patients receiving cytotoxic chemotherapy, and to mobilise peripheral blood progenitor cells. The CHMP concluded Neuzafy is highly similar to the reference product Neupogen with comparable quality, safety and efficacy.
How to interpret the evidence
The opinion covers paediatric use: the EMA states safety and efficacy are similar in adults and children receiving cytotoxic chemotherapy and includes PBPC mobilisation and congenital or cyclic neutropenias. The CHMP opinion must be followed by a European Commission decision; national availability and labelling in EU languages will follow after authorisation.
What remains uncertain?
A CHMP positive opinion is not the final EU marketing authorisation and does not guarantee immediate availability in Malta or other member states. Neuzafy is a biosimilar, not a new active substance. This summary is informational, not prescribing advice; consult product documents and national regulators once authorisation is granted.
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This summary was prepared with AI assistance and checked automatically against the linked primary source. It has not been individually reviewed by a clinician.