Aurobindo Arm CuraTeQ Gets Health Canada NOC for Pegfilgrastim Biosimilar Dyrupe
Hyderabad: CuraTeQ Biologics Private Limited, a wholly owned subsidiary of Aurobindo Pharma Limited, has received a Notice of Compliance (NOC) from Health Canada for Dyrupeg, its pegylated filgrastim biosimilar, the company informed stock exchanges on Friday.
In a regulatory disclosure, Aurobindo Pharma said that the NOC was granted by Health Canada’s Biologics and Radiopharmaceutical Drugs Directorate (BRDD) following a successful review of the product’s safety, efficacy, and quality.
A Notice of Compliance is issued by Health Canada after the regulator determines that a product meets all requirements under the Food and Drug Regulations. For Dyrupeg, the NOC confirms that the biosimilar has demonstrated high similarity to the approved reference biologic, with no clinically meaningful differences in terms of safety, pharmacokinetics/pharmacodynamics (PK/PD), or quality attributes.
Dyrupeg is CuraTeQ’s pegylated filgrastim biosimilar, used to reduce the incidence of infection in patients receiving certain types of chemotherapy. The approval marks another regulatory milestone for CuraTeQ’s growing biosimilars portfolio in regulated markets.
The company noted that Dyrupeg had already received marketing authorisation in 2025 from the European Commission (EC) and the UK Medicines and Healthcare products Regulatory Agency (MHRA), expanding its presence across major global markets.
In addition, Aurobindo Pharma disclosed that three other biosimilar applications from CuraTeQ Biologics are currently under review with Health Canada, signalling the company’s continued focus on expanding its biologics footprint in Canada.
Aurobindo Pharma Limited, headquartered in Hyderabad, is among India’s pharmaceutical companies with a global presence across regulated and emerging markets. CuraTeQ Biologics serves as the group’s dedicated biologics arm, focusing on the development and commercialisation of biosimilars for global markets.
