SciFocus/Dec 14, 2024 — CuraTeQ Biologics, a wholly-owned subsidiary of Aurobindo Pharma, has secured a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for Zefylti, a filgrastim biosimilar. This marks a significant milestone in expanding the company’s biosimilar portfolio in the European Union.
“After receiving the GMP certificate of compliance from the EMA in November, Zefylti is our first biosimilar to achieve this milestone. We remain confident in bringing advanced treatment options to patients in 2025.”
Highlights
- What is Zefylti?
- Zefylti (BP13) is a biosimilar of filgrastim, designed to treat neutropenia and facilitate the mobilisation of peripheral progenitor cells (PBPCs).
- It will be available in two formulations: 30 MU/0.5 mL and 48 MU/0.5 mL.
- EMA Approval Status
- CHMP recommendation is a key step towards receiving full marketing authorisation in the EU.
- Biosimilar Pipeline
- CuraTeQ has two additional biosimilars, pegylated filgrastim (BP14) and trastuzumab (BP02), under EMA review.
- Another biosimilar, bevacizumab (BP01), is being reviewed by the UK Medicines and Healthcare products Regulatory Agency (MHRA).
- Market Movement
- Aurobindo Pharma shares closed at ₹1,207.95 on the BSE, down by ₹7.20 or 0.59% on the announcement date.
About Filgrastim
Filgrastim is a recombinant DNA-derived protein that helps boost white blood cell counts, commonly prescribed for cancer patients undergoing chemotherapy or those with severe neutropenia.
Broader Context
This approval is expected to enhance access to affordable treatment options for patients across Europe, aligning with Aurobindo’s strategy of global biosimilar expansion.
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Website: https://curateqbio.com/
Article excerpt reposted from CNBCTV18.
