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.

Aurobindo Pharma Limited has achieved a significant regulatory milestone through its subsidiary Curateq Biologics, which has received approval from Health Canada for its Dyrupeg biosimilar product. This approval marks an important step in the company's biologics portfolio expansion and entry into the Canadian market.

Regulatory Approval Details

Health Canada has granted approval for Dyrupeg, confirming that the biosimilar product meets the comprehensive safety, efficacy, and quality standards mandated by Canadian regulatory authorities. The approval process involves rigorous evaluation of clinical data and manufacturing standards to ensure the biosimilar demonstrates comparable therapeutic effects to the reference product.

Strategic Significance

The Health Canada approval for Dyrupeg represents a crucial development for Curateq Biologics and strengthens Aurobindo Pharma's position in the biosimilars market. This regulatory success demonstrates the company's capability to develop complex biological products that meet international regulatory standards and opens opportunities for market penetration in Canada.

The approval validates Curateq Biologics' research and development capabilities and manufacturing processes, positioning the subsidiary as a credible player in the competitive biosimilars landscape. This achievement may serve as a foundation for future regulatory submissions and product launches in the Canadian market.