CuraTeQ Biologics Private Limited, a wholly owned subsidiary of Aurobindo Pharma Ltd, has received a Notice of Compliance (NOC) from Health Canada’s Biologics and Radiopharmaceutical Drugs Directorate (BRDD) for Dyrupeg™, its pegylated filgrastim biosimilar.
The NOC is granted following a successful regulatory review and confirms that Dyrupeg™ meets Health Canada’s requirements for safety, efficacy and quality under the Food and Drug Regulations. For Dyrupeg™, the approval signifies that Health Canada has determined the product to be highly similar to an approved reference biologic, with no clinically meaningful differences observed in terms of safety, pharmacokinetics/pharmacodynamics (PK/PD), or quality attributes.
Dyrupeg™ has already secured marketing authorisation in major global markets. In 2025, the biosimilar received approval from the European Commission (EC) for use across the European Union, as well as authorisation from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).
CuraTeQ Biologics continues to expand its biosimilar pipeline, with three additional biosimilar applications currently under review by Health Canada for potential marketing authorisation.
