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Aurobindo Pharma’s CuraTeQ Biologics Clinches UK MHRA Nod for Zefylti, Boosting Global Biosimilars Ambitions

Updated: May 13, 2025 19:02

Image Source: Telangana Navanirmana Sena
Aurobindo Pharma’s biosimilars arm, CuraTeQ Biologics, has achieved a major regulatory milestone with the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) granting marketing authorization for Zefylti, its biosimilar version of filgrastim. This approval marks a significant step for the Hyderabad-based company as it expands its presence in the high-growth biosimilars market across Europe.
 
Key Highlights:
  • MHRA Approval Secured: CuraTeQ Biologics, a wholly owned subsidiary of Aurobindo Pharma, received the green light from the UK MHRA for Zefylti, a biosimilar of filgrastim. The drug is indicated for the treatment of neutropenia and for mobilizing peripheral progenitor cells in cancer patients.
  • Market Expansion: Zefylti will be available in the UK in two dosage strengths: 30 MU/0.5 mL and 48 MU/0.5 mL, administered via injection. This approval follows a positive opinion from the European Medicines Agency’s CHMP, reinforcing CuraTeQ’s credibility in regulated markets.
  • Strategic Pipeline: Zefylti is the first biosimilar from CuraTeQ to receive such positive regulatory feedback in Europe. The company is also advancing biosimilar versions of pegylated filgrastim and trastuzumab, with a bevacizumab biosimilar under review by the MHRA.
  • Oncology Focus: Filgrastim is widely used to reduce infection risk in cancer patients undergoing chemotherapy or bone marrow transplants, making Zefylti a cost-effective alternative for healthcare systems and patients.
  • Company Momentum: This regulatory success strengthens Aurobindo Pharma’s biosimilar portfolio and signals its readiness to compete in global markets, with further launches expected in the near future.
With the UK MHRA’s nod for Zefylti, Aurobindo Pharma and CuraTeQ Biologics are poised for accelerated growth in the biosimilars space, promising broader access to critical oncology treatments.
 
Sources: Medical Dialogues, Times of India, Indian Pharma Post, Pharmacy Biz, CuraTeQ Biologics

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