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CuraTeQ Biologics, a subsidiary of Aurobindo Pharma, has obtained a Discover of Compliance (NOC) from Well being Canada’s Biologics and Radiopharmaceuticals Directorate for its pegylated filgrastim biosimilar model, Dyrupeg.
A Discover of Compliance from Well being Canada is issued to a drug producer after the product passes a assessment to make sure that it meets regulatory requirements for security, efficacy, and high quality underneath the Meals and Drug Rules.
For dilpeg, Aurobindo Pharma mentioned on Friday, the NOC verified excessive similarity to Well being Canada-approved reference biologics and particularly demonstrated no clinically significant variations by way of security, PK/PD and high quality traits.
In 2025, Dilpeg had obtained advertising authorization within the European Union from the European Fee and the UK’s MHRA. Three different biosimilar purposes from CuraTeQ Biologics are looking for advertising approval and are presently underneath assessment with Well being Canada, the corporate mentioned.
