Aurobindo Pharma’s CuraTeQ Biologics set for major breakthrough as CHMP backs Dazublys cancer biosimilar

CuraTeQ Biologics s.r.o., a wholly owned step-down subsidiary of Aurobindo Pharma Limited, has reached a key regulatory milestone as the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) delivered a positive opinion recommending the marketing authorization of Dazublys, its trastuzumab biosimilar. Announced on April 26, 2025, this endorsement underscores Aurobindo Pharma Limited’s strategic expansion into the high-value biosimilars market, particularly in oncology and immunology.

Pending final approval from the European Commission, anticipated by July 2025, Dazublys will soon be available across European Union member states. The product targets HER2-positive metastatic and early breast cancers, a segment where demand for effective and accessible biologics is rapidly growing.

Why Is Dazublys’s CHMP Positive Opinion a Significant Achievement for Aurobindo Pharma?

Aurobindo Pharma’s leadership has emphasized that the CHMP’s decision is rooted in comprehensive analytical and clinical data establishing biosimilarity between Dazublys and Roche’s reference biologic, Herceptin. Dr. Satakarni Makkapati, Director of Aurobindo Pharma and CEO of Biologics, Vaccines and Peptides, stated that Dazublys demonstrated no meaningful clinical differences across pharmacokinetics, pharmacodynamics, efficacy, safety, and immunogenicity parameters compared to Herceptin.

Dr. Makkapati also noted that this endorsement would further the company’s mission to expand access to life-saving cancer therapies, particularly in markets where affordability remains a concern. The positive opinion for Dazublys follows a string of regulatory successes, including the UK MHRA’s approval of Bevqolva, a bevacizumab biosimilar, in November 2024.

How Does Trastuzumab Impact HER2-Positive Cancer Treatments?

Trastuzumab is a targeted monoclonal antibody that binds specifically to the HER2 receptor, which is overexpressed in certain breast and gastric cancers. By disrupting HER2’s ability to transmit growth signals, trastuzumab effectively inhibits cancer cell proliferation and can also activate immune responses against tumors. The advent of trastuzumab revolutionized outcomes for HER2-positive breast cancer patients, transforming a once highly aggressive cancer subtype into a far more manageable condition.

Dazublys, as a biosimilar of trastuzumab, is expected to enhance access to this critical treatment option, particularly in healthcare systems across Europe that actively promote biosimilar adoption to curb oncology treatment costs.

How Does This Positive Opinion Advance Aurobindo Pharma’s Biosimilar Strategy?

Vice Chairman and Managing Director Mr. Nithyananda Reddy highlighted that the positive CHMP opinion on Dazublys marks the third endorsement for a CuraTeQ Biologics product within just five months. He reaffirmed Aurobindo Pharma’s commitment to launching at least 10 biosimilars by 2030, with a strong focus on oncology and immunology, reinforcing biosimilars as one of Aurobindo’s core business pillars.

This consistent regulatory momentum reflects Aurobindo Pharma’s evolving capabilities in complex biologics, moving the company beyond its traditional strengths in generic pharmaceuticals. Industry experts suggest that early movers with robust R&D and manufacturing capabilities, such as Aurobindo Pharma and CuraTeQ Biologics, are well-positioned to dominate the next phase of biosimilar market growth.

How Is CuraTeQ Biologics Positioned in the Global Biosimilars Arena?

Operating out of Hyderabad, India, CuraTeQ Biologics Private Limited is at the forefront of Aurobindo Pharma’s biologics strategy. With fourteen biosimilar candidates in its development pipeline, CuraTeQ focuses heavily on therapeutic areas with high unmet medical needs, particularly cancers and autoimmune diseases.

The company’s integrated capabilities from bulk drug substance manufacturing to final packaging allow it to exercise greater control over quality and regulatory compliance. CuraTeQ’s overarching vision is to make high-quality biologic therapies accessible and affordable globally, a strategy that dovetails with evolving healthcare demands, particularly across emerging markets and publicly funded healthcare systems.

How Does Aurobindo Pharma’s Core Pharmaceutical Business Support Its Biosimilars Expansion?

Aurobindo Pharma Limited has built a reputation as one of India’s leading integrated pharmaceutical companies, with operations spanning over 150 countries. Its product portfolio extends across seven therapeutic areas, including Central Nervous System (CNS) disorders, Anti-Retrovirals (ARVs), Cardiovascular (CVS) treatments, Antibiotics, Gastroenterology, Anti-Diabetics, and Anti-Allergics.

With more than 30 manufacturing and packaging facilities globally approved by key regulatory bodies such as the USFDA, UK MHRA, EDQM, and Japan PMDA, Aurobindo Pharma is leveraging its manufacturing scale, regulatory track record, and research-driven culture to accelerate its biosimilar ambitions.

The company’s experience in navigating complex regulatory landscapes gives it a strategic edge as it expands into regulated markets like Europe and the United States with its growing portfolio of high-value biosimilars.

What Is the Stock Market Sentiment Around Aurobindo Pharma Following the Dazublys Announcement?

Following the announcement, Aurobindo Pharma’s shares (NSE: AUROPHARMA, BSE: 524804) displayed moderate intraday gains as market sentiment turned cautiously optimistic. As of April 25, 2025, the stock closed at ₹1,220.10, reflecting a slight 3.00% decline from the previous session but an overall 4.14% increase over the past week.

Analysts maintain a broadly positive outlook on Aurobindo Pharma’s stock. Out of 25 covering analysts, 10 issued a “Strong Buy” rating, 9 recommended “Buy,” 2 suggested “Hold,” and 2 advised “Sell.” The company’s trailing twelve-month Price-to-Earnings (P/E) ratio stands at 22.31, notably below the pharmaceutical sector average of 28.96, suggesting potential undervaluation.

From an institutional standpoint, Foreign Institutional Investors (FIIs) marginally reduced their holdings from 16.29% to 15.33% in the March 2025 quarter, reflecting some caution. Meanwhile, Domestic Institutional Investors (DIIs) increased their stake from 25.21% to 26.23%, indicating growing domestic confidence in Aurobindo Pharma’s strategic direction.

Short-term sentiment could remain influenced by broader market volatility and regulatory updates; however, experts believe the biosimilar milestones, including Dazublys, could unlock medium-term value for shareholders. Given its strong pipeline and diversification strategy, Aurobindo Pharma is increasingly seen as a compelling “Buy” candidate for long-term investors focused on the healthcare sector.

What Lies Ahead for Aurobindo Pharma and CuraTeQ Biologics?

As biosimilar competition intensifies globally, differentiation will increasingly hinge on manufacturing quality, regulatory compliance, clinical performance, and cost leadership. Aurobindo Pharma’s combination of deep manufacturing capabilities, regulatory acumen, and robust biosimilar pipeline positions it favourably to gain share in the expanding biosimilars market.

With Dazublys expected to secure final European Commission approval by mid-2025, Aurobindo Pharma is poised to strengthen its presence in the high-growth oncology biosimilars space, reinforcing its long-term vision of delivering affordable, high-quality healthcare solutions to patients worldwide.