Aurobindo Pharma Secures Health Canada Nod for Pegfilgrastim Drug

Aurobindo Pharma pegfilgrastim biosimilar has received a major boost after the company’s wholly owned biosimilars subsidiary, CuraTeQ Biologics, secured regulatory clearance in Canada.

Canadian health regulator, Health Canada has issued a Notice of Compliance to the use of Dyrupeg and this is an indication that the drug is approved to be used in the country and commercial launch is in the offing.

Dyrupeg is a biological analog of pegfilgrastim, a long-acting medication that is indicated to prevent cancer patients, who are undergoing chemotherapy, against infection. The drug functions on the stimulation of the production of neutrophils which is an important form of white blood cell that facilitates the body to combat infection during intense cancer treatment.

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Aurobindo Pharma pegfilgrastim biosimilar with this approval enhances the influence of the company in the regulated global markets. The approvals of Dyrupeg in Europe and the United Kingdom have already been granted, and the Canadian nod has proven the quality of the product, its safety and effectiveness in relation to the rigid regulations of the country.

The company claimed that the approval helps it in its wider strategy to increase its biosimilars portfolio in some of the major international markets. CuraTeQ Biologics already has 3 other biosimilar products awaiting approval by Health Canada which means that there is more to be launched in the coming years.

This will also enhance the accessibility of patients to affordable biologic therapies in Canada where biosimilars are increasingly regarded as a means of lowering the healthcare costs without diminishing the treatment outcomes. In the case of Aurobindo pharma, the recent clearance is a strategy that strengthens its long-term orientation towards complex injectables and biologics, and its competitive stance in the global segment of oncology support care.