Aurobindo Pharma’s Dyrupeg faces Health Canada compliance notice

New Delhi: Aurobindo Pharma Ltd on Friday said its arm CuraTeQ Biologics Pvt Ltd has received a notice of compliance from Health Canada for its biosimilar Dyrupeg, indicated to cancer patients with low levels of neutrophils, a type of white blood cell.

CuraTeQ Biologics has obtained Notice of Compliance (NOC) from Biologics and Radiopharmaceutical Drugs Directorate (BRDD) for Dyrupeg, its pegylated filgrastim biosimilar version, Aurobindo Pharma said in a regulatory filing.

A NOC from Health Canada is issued to a drug manufacturer after a successful review, confirming the product meets regulatory standards for safety, efficacy, and quality under the food and drug regulations, it added.


For Dyrupeg, the company said the NOC specifically indicates that Health Canada has verified high similarity to an approved reference biologic drug, with no clinically meaningful differences in terms of safety or other quality attributes.

In 2025, Dyrupeg received marketing authorisation in the European Union from the European Commission (EC) and from MHRA, UK, it added.