Earlier this month, Aurobindo Pharma’s filgrastim biosimilar Zefylti achieved a positive opinion from EMA's CHMP
CuraTeQ Biologics, a wholly owned subsidiary of Aurobindo Pharma, has received marketing authorisation from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for Bevqolva, a biosimilar version of bevacizumab.
Bevacizumab, sold under the brand name Avastin among others, is used in the treatment of multiple cancers including metastatic colorectal cancer, recurrent or metastatic non-squamous non-small cell lung cancer, advanced and/or metastatic renal cell carcinoma, cervical cancer, and epithelial ovarian, fallopian tube and primary peritoneal cancer.
It blocks a protein called VEGF, which some cancer cells need to grow. The drug is used together with other chemotherapy medications.
Administered only via intravenous infusion, Bevqolva will be available as a 25 mg/mL concentrate in 4 mL (100 mg) and 16 mL (400 mg) single-use vials.
CuraTeQ Biologics, headquartered in Hyderabad, India, specialises in developing ‘high-quality, cost-effective’ biosimilars for oncology and autoimmune disease treatment. The company’s pipeline includes 14 biosimilars, primarily targeting the immunology and oncology segments
Earlier this month, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for its filgrastim biosimilar Zefylti, recommending the granting of a marketing authorisation.
Zefylti is intended for the treatment of neutropenia (a deficiency of certain white blood cells) and the mobilisation of peripheral progenitor cells (PBPCs). It will be available in two dosage strengths: 30 MU/0.5 mL and 48 MU/0.5 mL.
This would be a cost-effective alternative to filgrastim, which is usually given as a daily injection to stimulate the production of white blood cells and reduce the risk of infection in patients receiving certain cancer medications or undergoing a bone marrow transplant
A company spokesperson stated, "After receiving the GMP certificate of compliance from the EMA in November, Zefylti is our first biosimilar to achieve a positive opinion from EMA's CHMP."
The spokesperson further noted that the EMA is currently reviewing the company’s biosimilar versions of pegylated filgrastim and trastuzumab (used to treat breast and stomach cancers), expressing optimism that these treatment options will become available to patients in the coming year.
