Aurobindo Pharma gets Health Canada nod for biosimilar Dyrupeg

Aurobindo Pharma said its subsidiary CuraTeQ Biologics has received a Notice of Compliance from Health Canada for its biosimilar Dyrupeg, used to treat cancer patients with low neutrophil levels, following a successful regulatory review

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 for cancer patients with low levels of neutrophils, a type of white blood cell.

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

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A NOC from Health Canada is issued to a drug manufacturer after a successful review, confirming that 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 a high level of 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 the MHRA in the UK, it added.