Aurobindo Arm CuraTeQ Secures Health Canada Nod for Cancer Biosimilar Bevqolva
New Delhi: Aurobindo Pharma on Friday said its arm CuraTeQ Biologics has received a compliance notice from Health Canada's Biologics and Radiopharmaceutical Drugs Directorate for its bevacizumab biosimilar Bevqolva, indicated in the treatment of different types of cancer.
Health Canada issues an NOC (notice of compliance) after a successful review, granting formal marketing authorisation to the biosimilar by confirming it meets regulatory standards for safety, efficacy, and quality - comparable to the reference biologic drug under the Food and Drug Regulations, Aurobindo Pharma said in a regulatory filing.
Available in 100 mg and 400 mg formulations, the originator product Avastin is marketed by Roche/Genentech, it added.
Bevacizumab, a humanised monoclonal antibody, inhibits the formation of new blood vessels and slows tumour vascular growth and treats multiple cancers, including colorectal and lung, it added.
CuraTeQ Biologics also has two additional biosimilar applications under review by Health Canada, the filing said.
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