Aurobindo Pharma's Wholly-Owned Subsidiary, CuraTeQ Biologics, Receives Positive CHMP Opinion for Zefylti

In a significant development, CuraTeQ Biologics Private Limited, a wholly-owned subsidiary of Aurobindo Pharma, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for its filgrastim biosimilar, Zefylti. This recommendation positions the biosimilar for potential marketing authorisation.

Based in Hyderabad, Aurobindo Pharma noted that Zefylti marks its first biosimilar to gain a positive opinion from the EMA's CHMP, following the receipt of the GMP certificate from the EMA in November this year. The biosimilar, codenamed BP13, is designed for treating neutropenia and mobilising peripheral progenitor cells (PBPCs), and will be available in dosages of 30 MU per 0.5 mL and 48 MU per 0.5 mL.

Furthermore, Aurobindo Pharma revealed that two additional biosimilars, versions of pegylated filgrastim (BP14) and trastuzumab (BP02), are currently under review with the EMA. Meanwhile, a biosimilar to bevacizumab (BP01) is being reviewed by the UK-MHRA. The company expressed confidence in bringing these treatment options to patients next year.

CuraTeQ, headquartered in Hyderabad, is a global biopharmaceutical company focused on developing biosimilars for various cancers and autoimmune diseases. With a pipeline of 14 biosimilars targeting oncology and immunology segments, the company boasts end-to-end capabilities in producing a range of products, from bulk drug substances to packaged drug products.