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CuraTeQ Biologics Subsidiary Gets Health Canada NOC for Biosimilar Dyrupeg
Aurobindo Pharma Limited
January 9, 2026, 09:48 AM
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CuraTeQ Biologics Private Limited, a wholly owned subsidiary of Aurobindo Pharma Ltd, has received a Notice of Compliance (NOC) from the Biologics and Radiopharmaceutical Drugs Directorate (BRDD) of Health Canada for its biosimilar product, Dyrupeg™, a pegylated filgrastim biosimilar.
A Notice of Compliance from Health Canada signifies that a drug product has undergone a successful review and meets the required regulatory standards for safety, efficacy, and quality as per the Food and Drug Regulations. Health Canada's verification for Dyrupeg™ confirms its high similarity to an approved reference biologic drug, with no clinically meaningful differences in safety, pharmacokinetics/pharmacodynamics (PK/PD), or quality attributes.
This development follows earlier marketing authorizations for Dyrupeg™ received in 2025 from the European Commission (EC) in the European Union and from the MHRA in the UK. Additionally, CuraTeQ Biologics has three other biosimilar applications currently under review with Health Canada.
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