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 advisable granting advertising 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 yr.
Zefylti, codenamed BP13, is meant for the therapy of neutropenia and the mobilization of peripheral progenitor cells (PBPCs). It shall be accessible 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 worldwide biopharmaceutical firm targeted on growing biosimilars for the therapy of varied cancers and autoimmune illnesses. It at present has a pipeline of 14 biosimilars for the oncology and immunology segments.
The firm has finish-to-finish capabilities in producing a spread of merchandise, from bulk drug substances to fill-end and packaged drug merchandise.
