Aurobindo Pharma Ltd. on Friday (December 13) announced that its wholly-owned subsidiary, CuraTeQ Biologics Private Ltd, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for Zefylti (BP13), a Filgrastim biosimilar.
“…the Committee for Medicinal Products for Human Use (CHMP) within the European Medicines Agency (EMA) has adopted a positive opinion for Zefylti (BP13, a filgrastim biosimilar) recommending the granting of a marketing authorisation to CuraTeQ Biologics Private Limited, a wholly-owned subsidiary of the company,” Aurobindo Pharma said in a regulatory filing.
The CHMP recommendation is a critical step towards obtaining marketing authorisation for Zefylti in the European Union. 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 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.”
Article excerpt reposted from CNBCTV18.
