CuraTeQ Biologics' Zefylti (Filgrastim Biosimilar) Receives Positive CHMP Opinion for EU Approval
核心洞察
CuraTeQ Biologics (搜索)' Zefylti, a biosimilar of filgrastim, has received a positive opinion from the EMA's CHMP, recommending marketing authorization in the EU.
Zefylti is indicated for the treatment of neutropenia (搜索) and the mobilization of peripheral blood progenitor cells (PBPCs) in patients.
This marks CuraTeQ's first biosimilar to receive a positive CHMP opinion after obtaining GMP certificate of compliance from the EMA in November.
CuraTeQ Biologics (搜索), a subsidiary of Aurobindo Pharma, has announced that its biosimilar filgrastim, Zefylti, received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), recommending marketing authorization in the European Union. Zefylti, also known as BP13, is intended for the treatment of neutropenia (搜索) and the mobilization of peripheral blood progenitor cells (PBPCs). It will be available in 30 MU/0.5 mL and 48 MU/0.5 mL dosage forms.
This positive opinion marks a significant milestone for CuraTeQ Biologics (搜索), representing its first biosimilar to reach this stage following the receipt of a Good Manufacturing Practice (GMP) certificate of compliance from the EMA in November. The company anticipates launching Zefylti in the European market soon, pending final approval from the European Commission.
Addressing Neutropenia and PBPC Mobilization
Neutropenia (搜索), a condition characterized by abnormally low levels of neutrophils (a type of white blood cell), often results from chemotherapy or other immunosuppressive treatments. This increases the risk of infection and can significantly impact patient outcomes. Filgrastim, a granulocyte colony-stimulating factor (G-CSF), stimulates the production of neutrophils, thereby reducing the duration and severity of neutropenia.
Furthermore, filgrastim is used to mobilize PBPCs, which are collected and used in hematopoietic stem cell transplantation. This procedure is crucial for patients undergoing high-dose chemotherapy or radiation therapy for certain cancers and blood disorders.
CuraTeQ's Expanding Biosimilar Portfolio
In addition to Zefylti, CuraTeQ Biologics (搜索) has several other biosimilar candidates under review with regulatory agencies. These include biosimilar versions of pegylated filgrastim (BP14), trastuzumab (BP02), and bevacizumab (BP01). The applications for pegylated filgrastim and trastuzumab are currently under review with the EMA, while the bevacizumab biosimilar is under review with the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. The company anticipates bringing these treatment options to patients in the coming year.
"After receiving the GMP certificate of compliance from the European Medicines Agency (EMA) in November, Zefylti is our first biosimilar to receive a positive opinion from EMA's CHMP. 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 MHRA. We are confident and on track to bring these treatment options to patients next year," said a company spokesperson.