AUROPHARMANSEAurobindo Pharma Limited· PharmaceuticalsHighPositive
Announced Fri, 9 Jan · 15:18 IST

Aurobindo Pharma Limited has informed the Exchange about receipt of Notice of Compliance from Health Canada for Dyrupeg biosimilar

Regulatory Product ApprovalBusiness Updates View source PDF

AUROPHARMA · price

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Price reaction · full curve

Awaiting price reaction for this filing.

AI summary

Aurobindo Pharma's wholly owned subsidiary CuraTeQ Biologics has received a Notice of Compliance (NOC) from Health Canada for Dyrupeg, a pegylated filgrastim biosimilar. The NOC confirms the product meets Canadian standards for safety, efficacy, and quality, and is highly similar to the approved reference biologic. This follows earlier marketing authorizations for Dyrupeg in the European Union and the UK during 2025. Three other biosimilar applications from CuraTeQ are currently under review with Health Canada. The approval opens the Canadian market for this product used in neutropenia treatment.

Likely market impact

Positive for Aurobindo Pharma as it expands the biosimilars portfolio into the Canadian market, adding a new revenue stream. However, the immediate financial impact may be limited as commercial launches and uptake will take time.