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.

Aurobindo Pharma 's wholly owned subsidiary CuraTeQ Biologics Private Limited has achieved a significant regulatory milestone with the receipt of Notice of Compliance from Health Canada for its biosimilar product Dyruppeg. The approval was announced on January 9, 2026, through a regulatory filing under SEBI Listing Regulations.

Regulatory Approval Details

The Notice of Compliance was issued by Health Canada's Biologics and Radiopharmaceutical Drugs Directorate for Dyruppeg, which is CuraTeQ Biologics' pegylated filgrastim biosimilar version. This regulatory approval represents a comprehensive validation of the product's compliance with Canadian healthcare standards.

Product Validation and Standards

The Notice of Compliance from Health Canada confirms that Dyruppeg meets stringent regulatory requirements across multiple parameters. The approval process involved a successful review confirming the product meets regulatory standards for safety, efficacy, and quality under the Food and Drug Regulations.

Health Canada has specifically verified high similarity to an approved reference biologic drug, with no clinically meaningful differences in terms of safety, pharmacokinetics/pharmacodynamics, or quality attributes. This validation demonstrates the biosimilar's therapeutic equivalence to the reference product.

Global Market Expansion

Dyruppeg has established a strong international presence through multiple regulatory approvals. In 2025, the product received marketing authorization in the European Union from the European Commission and from the Medicines and Healthcare products Regulatory Agency in the United Kingdom.

Pipeline Development

CuraTeQ Biologics maintains an active development pipeline with Health Canada, demonstrating continued commitment to the Canadian biosimilar market. The company currently has three additional biosimilar applications seeking marketing authorization that are under review with Health Canada.

This regulatory success reinforces Aurobindo Pharma's strategic focus on biosimilar development through its specialized subsidiary, positioning the company for continued growth in international biosimilar markets across North America and Europe.