HYDERABAD: Aurobindo Pharma’s wholly-owned subsidiary, CuraTeQ Biologics Private Limited, obtained a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European drug regulatory physique, the European Medicines Agency (EMA), for its filgrastim biosimilar, Zefylti. The committee really helpful granting advertising and marketing authorisation.
The Hyderabad-based firm acknowledged that Zefylti is its first biosimilar to obtain a positive opinion from the EMA’s CHMP after it obtained the GMP (good manufacturing practices) certificates from the EMA in November this 12 months.
Zefylti, codenamed BP13, is meant for the remedy of neutropenia and the mobilisation of peripheral progenitor cells (PBPCs). It shall be out there in dosages of 30 MU per 0.5 mL and 48 MU per 0.5 mL.
“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 UK-MHRA. We are confident and on track to bring these treatment options to patients next year,” Aurobindo Pharma acknowledged.
The Hyderabad-headquartered CuraTeQ is a world biopharmaceutical firm targeted on creating biosimilars for the remedy of varied cancers and autoimmune ailments. It presently has a pipeline of 14 biosimilars for the oncology and immunology segments.
The firm has end-to-end capabilities in producing a variety of merchandise, from bulk drug substances to fill-finish and packaged drug merchandise.
