Aurobindo Pharma subsidiary CuraTeQ Biologics has received positive opinion for Zefylti, its biosimilar of filgrastim, from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).
The CHMP has adopted a positive opinion for Zefylti (BP13) recommending the granting of a marketing authorisation. Zefylti will be available as 30 MU/0.5 mL and 48 MU/0.5 mL and is intended for the treatment of neutropenia and the mobilisation of peripheral progenitor cells (PBPCs), Aurobindo said on Friday.
“After receiving the GMP certificate of compliance from the EMA in November, Zefylti is our first biosimilar to receive a positive opinion from the CHMP. Our biosimilar versions of pegylated filgrastim (BP14) and trastuzumab (BP02) are 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,” the company said in a release.
Published – December 15, 2024 12:43 am IST
