Aurobindo Pharma arm CuraTeQ gets Health Canada nod for biosimilar
Aurobindo Pharma announced a significant development today. Its subsidiary, CuraTeQ Biologics, has received a compliance notice from Health Canada for its cancer drug Bevqolva. This approval marks a crucial step for the bevacizumab biosimilar. Bev...
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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