Hyderabad‑based pharmaceutical company Aurobindo Pharma’s biosimilars arm, CuraTeQ Biologics, has received a Notice of Compliance (NOC) from Health Canada’s Biologics and Radiopharmaceutical Drugs Directorate (BRDD) for its pegylated filgrastim biosimilar Dyrupeg.
The NOC confirms that Dyrupeg meets Canada’s regulatory standards for safety, efficacy and quality under the Food and Drug Regulations and has been determined to be highly similar to an approved reference biologic with no clinically meaningful differences in safety, pharmacokinetics or quality attributes.
Dyrupeg is indicated for use in supportive care to reduce the incidence of infection and febrile neutropenia in patients undergoing certain types of chemotherapy by helping the body produce neutrophils, a key type of white blood cell.
The approval in Canada follows earlier marketing authorisations for Dyrupeg in major regulated markets, including the European Union from the European Commission and from the UK’s Medicines and Healthcare products Regulatory Agency. CuraTeQ’s broader biosimilars pipeline continues to grow, with three additional applications currently under review with Health Canada.
The regulatory milestone strengthens Aurobindo’s global presence in the biosimilars segment and expands access to pegfilgrastim therapy for patients in Canada.
