Aurobindo Pharma 's wholly owned subsidiary, CuraTeQ Biologics Private Limited, has announced the successful completion of a pivotal Phase 3 clinical study for its denosumab biosimilar. The study, which compared the biosimilar to Prolia (denosumab), marks a significant milestone in the company's efforts to bring a new osteoporosis treatment option to market.

Study Details and Results

The Phase 3 clinical trial involved 446 women with postmenopausal osteoporosis and was conducted across 40 sites in five European countries. The study met all clinical endpoints, demonstrating no clinically meaningful differences between CuraTeQ's biosimilar and the reference product, Prolia.

Key findings of the study include:

• The primary endpoint, measuring the percentage change in Lumbar Spine Bone Mineral Density (LS-BMD) at Week 52, met the pre-defined equivalence margin of (-1.45, +1.45).
• The co-primary endpoint, assessing the area under the effect curve (AUEC) of serum C-terminal telopeptide (sCTX) from Week 0 to Week 26, fell within the acceptable range of (0.80, 1.25).
• These results satisfy regulatory criteria for both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Expert Commentary

Dr. Arpit Prajapati, Head of Clinical Sciences at CuraTeQ, commented on the study's significance: "The clinical trial was designed to evaluate the efficacy of the denosumab biosimilar in enhancing bone mineral density and mitigating fracture risk in postmenopausal women, a population that is particularly susceptible to osteoporosis. These findings suggest that CuraTeQ's denosumab biosimilar exhibits comparable efficacy to Prolia, highlighting its potential as a viable alternative for patients in need of osteoporosis treatment."

Regulatory Outlook

CuraTeQ is now setting its sights on the regulatory approval process. Dr. Disha Dadke, Head of R&D and Regulatory Sciences at CuraTeQ, outlined the company's plans: "CuraTeQ plans to submit regulatory filings for the denosumab biosimilar in the EU, US and other key regulated markets from January 2026. The company's regulatory team has consulted with the FDA and is actively engaging with other regulatory authorities to ensure a smooth filing and an efficient review process."

Market Implications

The successful completion of this Phase 3 study positions CuraTeQ Biologics and its parent company, Aurobindo Pharma Limited, to potentially enter the lucrative market for osteoporosis treatments. Denosumab, marketed as Prolia by Amgen, is a widely used medication for treating osteoporosis in postmenopausal women and has been a significant revenue generator in the global pharmaceutical market.

As biosimilars typically offer more affordable alternatives to branded biologics, the introduction of CuraTeQ's denosumab biosimilar could potentially increase access to this important osteoporosis treatment for patients worldwide, pending regulatory approvals.

Investors and industry observers will likely be watching closely as CuraTeQ progresses towards its planned regulatory submissions in early 2026, which could mark the beginning of a new chapter in the company's growth and in the broader landscape of osteoporosis treatment options.

Aurobindo Pharma , a leading Indian pharmaceutical company, has announced the establishment of a new wholly-owned subsidiary in Malaysia, marking a significant step in its global expansion strategy.

New Subsidiary Details

The new entity, named Aurobindo Pharma (Malaysia) SDN. BHD., was incorporated on September 17, 2025, through Helix Healthcare B.V., an existing wholly-owned subsidiary of Aurobindo Pharma. The Malaysian subsidiary has been established with an initial share capital of RM 400,000 (approximately USD 100,000.00), divided into 400,000 shares with a nominal value of RM 1.00 each.

Strategic Objectives

The primary objective behind the incorporation of this new subsidiary is to expand Aurobindo Pharma's pharmaceutical products business in Malaysia. This move aligns with the company's broader strategy to strengthen its presence in international markets and diversify its geographical footprint.

Regulatory Compliance

According to the company's disclosure to the National Stock Exchange of India Limited and BSE Limited, the incorporation of Aurobindo Pharma (Malaysia) SDN. BHD. did not require any governmental or regulatory approvals. The transaction was completed through a 100% cash subscription to the share capital.

Corporate Structure

As a wholly-owned subsidiary of Helix Healthcare B.V., which is, in turn, a wholly-owned subsidiary of Aurobindo Pharma Limited, the new Malaysian entity falls within the company's related party transactions. However, the company has clarified that promoters and promoter groups of Aurobindo Pharma are not interested in this transaction.

Industry Focus

The new subsidiary will operate within the pharmaceuticals industry, aligning with Aurobindo Pharma's core business. This strategic move is expected to enhance the company's ability to serve the Malaysian pharmaceutical market more effectively and potentially use it as a base for further expansion in the region.

Looking Ahead

While it's too early to assess the financial impact of this new subsidiary, as it was just incorporated, the move demonstrates Aurobindo Pharma's commitment to global growth and its confidence in the Malaysian pharmaceutical market. As the subsidiary begins operations, it will be interesting to observe how it contributes to Aurobindo Pharma's overall business performance and market presence in Southeast Asia.