HYDERABAD: Aurobindo Pharma’s wholly-owned subsidiary, CuraTeQ Biologics Private Limited, received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European drug regulatory body, the European Medicines Agency (EMA), for its filgrastim biosimilar, Zefylti. The committee recommended granting marketing authorisation.
The Hyderabad-based company stated that Zefylti is its first biosimilar to receive a positive opinion from the EMA’s CHMP after it received the GMP (good manufacturing practices) certificate from the EMA in November this year.
Zefylti, codenamed BP13, is intended for the treatment of neutropenia and the mobilisation of peripheral progenitor cells (PBPCs). It will be available 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 stated.
The Hyderabad-headquartered CuraTeQ is a global biopharmaceutical company focused on developing biosimilars for the treatment of various cancers and autoimmune diseases. It currently has a pipeline of 14 biosimilars for the oncology and immunology segments.
The company has end-to-end capabilities in producing a range of products, from bulk drug substances to fill-finish and packaged drug products.
