Aurobindo Pharma’s Curateq Gets Canada Nod For Biosimilar Dyrupeg

Aurobindo Pharma Ltd has announced that its step-down subsidiary, Curateq Biologics, has received a No Objection Certificate (NOC) from Canada’s health authority for Dyrupeg, a biosimilar version of pegfilgrastim. Dyrupeg is primarily used to reduce the risk of infection in cancer patients undergoing chemotherapy by stimulating white blood cell production. This regulatory clearance adds to Curateq’s growing list of international approvals, following earlier authorizations in Europe and the UK.  

Key highlights from the announcement include  

• Curateq Biologics received NOC from Canada’s health authority for Dyrupeg.  
• Dyrupeg is a pegfilgrastim biosimilar used in oncology to lower infection risks during chemotherapy.  
• The approval strengthens Curateq’s biosimilar pipeline, which includes products like Bevqolva and Zefylti.  
• Earlier, Dyrupeg had secured approvals from the European Medicines Agency (EMA) and the UK’s MHRA.  
• The clearance enhances Aurobindo Pharma’s global footprint in biosimilars, particularly in oncology and immunology segments.  
• Industry experts note that such approvals highlight India’s growing role in the global biosimilars market.  

This milestone underscores Aurobindo Pharma’s commitment to expanding its biosimilar portfolio worldwide. With Dyrupeg now cleared in Canada, the company is well-positioned to strengthen its presence in regulated markets and deliver affordable, high-quality biologics to patients globally.  

Sources: CuraTeQ Biologics, India Infoline, Aurobindo Pharma Corporate Filings