CHMP positive for Zefylti
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Zefylti, intended for the treatment of neutropenia and the mobilisation of peripheral blood progenitor cells (PBPCs)
The applicant for this medicinal product is CuraTeQ Biologics s.r.o., a subsidiary of Aurobindo
Zefylti will be available as 30 MU/0.5 ml and 48 MU/0.5 ml solution for injection or infusion in pre-filled syringe. The active substance of Zefylti 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.
Zefylti 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 Zefylti has comparable quality, safety and efficacy to Neupogen (filgrastim).
Aurobindo Pharma spokesperson said, “After receiving the GMP certificate of compliance from the European Medicines Agency (EMA) in November, Zefylti is our first biosimilar to receive a positive opinion from EMA’s CHMP. Two more products, our biosimilar versions of pegylated filgrastim (BP14) and trastuzumab (BP02), are currently under review with the EMA, and a biosimilar to bevacizumab (BP01) is under review with the MHRA. We are confident and on track to bring these treatment options to patients next year.”
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