Aurobindo Pharma: Health Canada clears Dyrupeg biosimilar

A key regulatory nod for Aurobindo’s biosimilars push

Aurobindo Pharma said its wholly owned biosimilars arm, CuraTeQ Biologics, has received a Notice of Compliance (NOC) from Health Canada for Dyrupeg, its pegylated filgrastim biosimilar. The company disclosed the development in a stock exchange intimation under SEBI Listing Regulations. For Indian drugmakers building biosimilar franchises outside the US, Canada is an important regulated market that can broaden the commercial runway for approved products. The Health Canada decision also adds to CuraTeQ’s earlier authorisations for the same product in Europe.

The filing explained what an NOC represents in the Canadian system. Aurobindo said an NOC is issued to a drug manufacturer after a successful review and confirms the product meets regulatory standards for safety, efficacy, and quality under the Food and Drug Regulations. For Dyrupeg specifically, the company added that Health Canada verified “high similarity” to an approved reference biologic drug, with “no clinically meaningful differences.”

What Health Canada cleared, and why it matters

According to the company’s disclosure, the NOC was granted by Health Canada’s Biologics and Radiopharmaceutical Drugs Directorate. The regulator’s review, as described by Aurobindo, covered safety, efficacy and quality, and concluded that the biosimilar is highly similar to the reference biologic. The filing also noted that the “no clinically meaningful differences” determination covered safety, PK/PD, and quality attributes.

For biosimilars, the similarity conclusion is central because it underpins market access discussions with payers and healthcare systems. While the company did not provide launch timelines or commercial estimates, the approval establishes regulatory eligibility to market the product in Canada subject to the local framework.

Dyrupeg: indication and patient use case

Aurobindo said Dyrupeg is a biosimilar of pegylated filgrastim. The company described the product as indicated for supportive care to prevent chemotherapy-induced neutropenia, which involves low levels of neutrophils, a type of white blood cell. The disclosure added that the medicine helps the body produce neutrophils after chemotherapy to lower the risk of serious infections and fever.

These supportive-care products are widely used alongside oncology regimens, and biosimilar competition typically focuses on ensuring dependable supply and broad reimbursement coverage, in addition to clinical comparability.

Global approvals already in place

Before Canada, Aurobindo said its biosimilars have also received marketing authorisation in the EU and UK. The company’s updates referenced that Dyrupeg received marketing authorisation in 2025 from the European Commission for the European Union and from the UK’s Medicines and Healthcare products Regulatory Agency.

The sequence reflects CuraTeQ’s focus on building a regulated-market footprint for the same molecule across multiple geographies, rather than a single-market strategy.

Pipeline status in Canada

Alongside the Dyrupeg NOC, the company’s stock exchange filing said CuraTeQ currently has three other biosimilar applications under review with Health Canada. Aurobindo did not name the products in those applications or provide expected decision dates. Still, the disclosure indicates the company is attempting to scale a portfolio, not just a single approval.

For investors tracking the business, the number of pending applications is a measurable indicator of development activity and regulatory engagement in Canada.

Other CuraTeQ and group-level developments investors are watching

The broader news flow around Aurobindo’s biosimilars business has included additional milestones. A Reuters item dated April 6 said Curateq Biologics announced positive phase 3 results for its omalizumab biosimilar BP11. Another Reuters item dated March 25 said Curateq Biologics entered a marketing and distribution agreement with Stada Arzneimittel AG.

Separately, the company’s updates referenced portfolio actions. CuraTeQ terminated a biosimilar agreement with US-based BioFactura for product BFI-751, citing portfolio prioritisation, and said the decision would not impact its broader biosimilars strategy.

Aurobindo’s base business and why biosimilars are a strategic add-on

Aurobindo Pharma operates a large generics and APIs business. The company describes itself as specialising in the research, development, manufacturing and marketing of active pharmaceutical ingredients and generic pharmaceuticals. Biosimilars can sit alongside this base by extending the company’s product complexity and by opening opportunities in markets where biologics account for a large share of drug spending.

At the same time, biosimilars require sustained investment in development, comparability packages, and manufacturing capabilities. Regulatory approvals such as the Canadian NOC are therefore closely watched because they validate the development program and manufacturing controls.

Market reaction

Aurobindo Pharma shares closed marginally lower on January 9, down 0.61% at ₹1,198.80 on the NSE, according to the report carrying the Health Canada update. The move suggests the day’s trading reflected a mix of factors, even as the company reported a regulatory milestone for CuraTeQ.

Key facts at a glance

Why this update matters

For CuraTeQ, the Canadian NOC adds another regulated-market clearance for a key supportive-care biosimilar, following Europe and the UK. The company’s own description of the NOC criteria also signals that the regulator’s assessment covered the standard parameters biosimilars are judged on: safety, efficacy and quality, alongside comparability to the reference product.

The next set of catalysts, based on what the company has already disclosed, are updates on the three additional Health Canada reviews and further progress on the biosimilars pipeline, including programs like BP11 where phase 3 results have been reported.

Conclusion

Aurobindo Pharma’s disclosure that CuraTeQ Biologics received Health Canada’s NOC for Dyrupeg strengthens the subsidiary’s international biosimilar track record. With EU and UK authorisations already in place and more Canadian filings under review, the company’s near-term news flow is likely to remain centred on regulatory decisions and portfolio execution.