Aurobindo Pharma arm’s biosimilar gets Health Canada NOC

CuraTeQ Biologics, a subsidiary of Aurobindo Pharma, has received a Notice of Compliance (NOC) from Health Canada’s Biologics and Radiopharmaceutical Drugs Directorate for Dyrupeg, its pegylated filgrastim biosimilar version.

Following a successful review, a Notice of Compliance is issued by Health Canada to the drug manufacturer, confirming that the product meets regulatory standards for safety, efficacy and quality under the Food and Drug Regulations.

For Dyrupeg, the NOC specifically indicates that Health Canada has confirmed high similarity with an approved reference biologic drug, with no clinically meaningful differences in terms of safety, PK/PD or quality characteristics, Aurobindo Pharma said on Friday.

In 2025, Dyrupeg received marketing authorization in the European Union from the European Commission and the MHRA, UK. It added that CuraTeQ Biologics has three other biosimilar applications seeking marketing authorization that are currently under review with Health Canada.