4 months ago
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Aurobindo Pharma subsidiary CuraTeQ Biologics has received announcement of compliance (NOC) from Health Canada’s Biologics and Radiopharmaceutical Drugs Directorate for Dyrupeg, its pegylated filgrastim biosimilar version.
A announcement of compliance from Health Canada is issued to a cause shaper aft a palmy review, confirming the merchandise meets regulatory standards for safety, efficacy and prime nether the Food and Drug Regulations.
For Dyrupeg, the NOC specifically indicates Health Canada has verified precocious similarity to an approved notation biologic drug, with nary clinically meaningful differences successful presumption of safety, PK/PD oregon prime attributes, Aurobindo Pharma said connected Friday.
In 2025, Dyrupeg had received selling authorisation successful the European Union from the European Commission and from MHRA, UK. There are 3 different biosimilar applications from CuraTeQ Biologics seeking selling authorisation that are presently nether reappraisal with Health Canada, it said.
