Aurobindo Pharma arm gets marketing authorisation for Zefylti in EU
Hyderabad: Aurobindo Pharma has announced that the European Commission (EC) has granted marketing authorization in the European Union (EU) for Zefylti, a filgrastim biosimilar, to CuraTeQ Biologics s.r.o., a wholly owned step-down subsidiary of the Company.
Earlier in December 2024, the Committee for Medicinal Products (CHMP) of EuropeanMedicines Agency has adopted positive opinion recommending the approval of Zefylti.
Zefylti is intended for the treatment of neutropenia and the mobilisation of peripheral progenitor cells (PBPCs).
Commenting on the update the company spokesperson had 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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