Aurobindo Pharma’s subsidiary, CuraTeQ Biologics, has received a Notice of Compliance (NOC) from Health Canada for its biosimilar version of Dyrupeg™. This approval, granted by the Biologics and Radiopharmaceutical Drugs Directorate (BRDD), confirms that Dyrupeg™ meets Canadian regulatory standards for safety, efficacy, and quality. Dyrupeg™ already has marketing authorization in the European Union since 2025.
Health Canada Approves CuraTeQ’s Dyrupeg™ Biosimilar
CuraTeQ Biologics Private Limited, a subsidiary of Aurobindo Pharma Ltd, has secured a significant regulatory approval from Health Canada. The company received a Notice of Compliance (NOC) for its biosimilar drug, Dyrupeg™.
Dyrupeg™ Biosimilar Details
Dyrupeg™ is a biosimilar version of pegylated filgrastim. The Notice of Compliance (NOC) from Health Canada confirms that the product meets the stringent regulatory standards for safety, efficacy, and quality mandated by the Canadian Food and Drug Regulations. This indicates that Health Canada has verified high similarity to a reference biologic drug, ensuring there are no clinically meaningful differences in safety or quality.
European Market Presence
Dyrupeg™ has already achieved a market presence in the European Union. In 2025, it received marketing authorization in the European Union from the European Commission (EC) and from MHRA in the UK. CuraTeQ Biologics also has other biosimilar applications seeking marketing authorization that are currently under review with Health Canada.
Source: BSE
