Aurobindo Pharma's Dyrupeg Gets Green Light from Health Canada

Aurobindo Pharma's subsidiary, CuraTeQ Biologics, has received a Notice of Compliance from Health Canada for its biosimilar Dyrupeg. The regulatory nod confirms the drug meets safety and quality standards, marking a significant milestone following earlier approvals in the EU and UK.

Aurobindo Pharma Ltd announced that its subsidiary, CuraTeQ Biologics Pvt Ltd, has received Health Canada's Notice of Compliance for its biosimilar product, Dyrupeg. This drug is designed for cancer patients experiencing low neutrophil levels, a critical component of the immune system.

The Notice of Compliance granted by the Biologics and Radiopharmaceutical Drugs Directorate marks a pivotal approval for Dyrupeg, a pegylated filgrastim biosimilar. This certification guarantees the drug adheres to stringent safety, efficacy, and quality standards.

Moreover, Health Canada's approval confirms Dyrupeg's similarity to an existing reference biologic drug, underscoring no significant clinical differences in safety or quality. This follows Dyrupeg's prior marketing authorization in the EU and UK, heralding a step forward in global market expansion.