Aurobindo Pharma Ltd announced on Friday that its subsidiary CuraTeQ Biologics Pvt Ltd has achieved a significant regulatory milestone with the receipt of Notice of Compliance (NOC) from Health Canada for its biosimilar drug Dyrupeg. This approval marks an important step in expanding the company's oncology portfolio in the Canadian market.

Regulatory Approval Details

The Notice of Compliance was issued by Health Canada's Biologics and Radiopharmaceutical Drugs Directorate (BRDD), the regulatory body responsible for overseeing biological and radiopharmaceutical products in Canada. The approval covers Dyrupeg, which is CuraTeQ Biologics' pegylated filgrastim biosimilar version.

Therapeutic Indication

Dyrupeg is specifically indicated for cancer patients experiencing neutropenia, a condition characterized by abnormally low levels of neutrophils. Neutrophils are a crucial type of white blood cell that plays a vital role in the body's immune system defense against infections. Cancer patients often develop neutropenia as a side effect of chemotherapy treatments, making them more susceptible to serious infections.

Market Significance

The Health Canada approval enables CuraTeQ Biologics to commercialize Dyrupeg in the Canadian pharmaceutical market. Biosimilar drugs offer cost-effective alternatives to original biological medicines while maintaining comparable safety and efficacy profiles. This approval strengthens Aurobindo Pharma's presence in the oncology supportive care segment through its specialized biologics subsidiary.

The company disclosed this development through a regulatory filing, highlighting the strategic importance of this approval for its biologics division's growth in international markets.

Aurobindo Pharma announced on January 9 that its biologics subsidiary CuraTeQ Biologics has received regulatory approval from Health Canada for its biosimilar product Dyrupeg. The Notice of Compliance (NOC) marks a significant milestone for the company's biologics division.

Regulatory Approval Details

CuraTeQ Biologics, a wholly owned subsidiary of Aurobindo Pharma, obtained the NOC after successfully completing Health Canada's comprehensive review process. The regulatory authority issues NOCs only after confirming that a product meets established safety, efficacy and quality standards.

The approval confirms Health Canada's satisfaction with Dyrupeg's compliance with regulatory requirements following their detailed assessment process.

Recent Corporate Developments

Earlier in January, Aurobindo Pharma expanded its domestic operations through a strategic acquisition. The company's subsidiary Auro Pharma Ltd acquired Khandelwal Laboratories' non-oncology prescription business for ₹325.00 crores.

This acquisition strengthens Aurobindo's presence in India's pain management and anti-infective therapeutic segments.

Portfolio Management and Regulatory Updates

In December, CuraTeQ Biologics made a strategic decision to terminate its biosimilar agreement with US-based BioFactura for product BFI-751. The company cited portfolio prioritisation as the reason for ending the partnership, stating that the decision would not impact its broader biosimilars strategy.

Additionally, the US Food and Drug Administration completed an inspection of Aurobindo's wholly owned subsidiary Apitoria Pharma Unit-V in Telangana. The FDA issued Form 483 with three procedural observations, which the company indicated would have no impact on operations.

Market Performance

Shares of Aurobindo Pharma Limited closed lower on the NSE on January 9, with the stock declining 0.61% to ₹1,198.80.