Notice of Compliance from Health Canada enables marketing authorisation for cancer biosimilar in Canadian market
Aurobindo Pharma has informed the National Stock Exchange of India that its wholly owned subsidiary, CuraTeQ Biologics, has received a Notice of Compliance (NOC) from Health Canada for Bevqolva, its bevacizumab biosimilar.
The approval was granted by Health Canada’s Biologics and Radiopharmaceutical Drugs Directorate (BRDD), allowing formal marketing authorisation for the biosimilar after confirming compliance with regulatory standards related to safety, efficacy and quality.
Bevacizumab is a humanised monoclonal antibody used in oncology treatment that works by inhibiting angiogenesis through blocking vascular endothelial growth factor A (VEGF-A). The therapy is used in the treatment of multiple cancers, including colorectal and lung cancer.
Bevqolva will be available in 100 mg and 400 mg formulations. The reference biologic drug, Avastin, is marketed globally by Roche and Genentech.
The company stated that Bevqolva had earlier secured marketing authorisation from the Medicines and Healthcare products Regulatory Agency in 2025 and has already been commercially launched in the UK market. The biosimilar is also currently under review by the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency.
CuraTeQ Biologics added that two additional biosimilar applications are presently under review by Health Canada.
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