CuraTeQ Biologics Private Limited, a wholly owned subsidiary of Aurobindo Pharma, has announced positive results from a pivotal Phase 3 clinical study of its denosumab biosimilar, developed as an alternative to Prolia (denosumab) for treating postmenopausal osteoporosis.

The study, conducted across 40 sites in five European countries on 446 postmenopausal women, met all clinical endpoints, showing no clinically meaningful differences between the biosimilar and the reference product.

Dr Arpit Prajapati, Head of Clinical Sciences at CuraTeQ, said the trial evaluated the biosimilar’s efficacy in improving bone mineral density (BMD) and reducing fracture risk. The primary endpoint — percentage change in lumbar spine bone mineral density (LS-BMD) at Week 52 — achieved the pre-defined equivalence margin of (-1.45, +1.45). The co-primary endpoint, measuring the area under the effect curve (AUEC) of serum C-terminal telopeptide (sCTX) from Week 0 to Week 26, was within the regulatory range of (0.80, 1.25), satisfying criteria set by the US FDA and the European Medicines Agency (EMA).

Dr Disha Dadke, Head of R&D and Regulatory Sciences at CuraTeQ, said the company plans to begin regulatory submissions for the denosumab biosimilar in the EU, US, and other key regulated markets starting January 2026. The company has already held consultations with the FDA and is engaging with other regulators to facilitate a smooth review process.

About CuraTeQ: CuraTeQ Biologics Private Limited, a subsidiary of Aurobindo Pharma Limited, is a global biopharmaceutical company headquartered in Hyderabad, India. The company is focused on developing biosimilars for the treatment of various cancers and autoimmune diseases. CuraTeQ’s pipeline consists of fourteen biosimilars, primarily targeting the immunology and oncology segments. It has end-to-end capabilities in producing a full range of products from bulk drug substance to fill-finish and packaged drug products.

Article excerpt reposted from: Trading View

CuraTeQ Biologics, (a wholly owned subsidiary of Aurobindo Pharma) has announced successful Phase I study results for its new bone treatment medicine. The drug, BP16, is a biosimilar referencing Denosumab (Prolia).

The company tested the drug on 204 healthy volunteers, comparing it with Prolia — the original version sold in Europe and the United States.

The drug works by blocking a protein called RANKL, which is responsible for breaking down bone tissue. This makes it useful for treating:

• Bone thinning (osteoporosis) in women after menopause
• Bone problems caused by cancer metastasis
• Bone weakness from cancer treatments

The successful trial is a key step towards bringing this potentially more affordable version of the medicine to patients.

Arpitkumar Prajapati, Head of Clinical Sciences at CuraTeQ Biologics, said, “The results from our study confirmed that BP16 exhibits a PK profile nearly identical to the reference products, achieving key bioequivalence parameters — maximum serum concentration and area under the curve — within the established bioequivalence range of 80-125%.”

“Additionally, BP16 demonstrated comparable pharmacodynamics, safety, and immunogenicity profiles to both EU and US versions of the reference product. The study, which included 204 subjects from Australia and New Zealand, successfully met all the predefined endpoints.”

Dr Disha Dadke, Head of R&D and Regulatory Sciences at CuraTeQ Biologics, said, “With the positive Phase 1 study results, we are optimistic about our ongoing Phase 3 study. This study is progressing across multiple sites in the EU, focusing on women with postmenopausal osteoporosis, and we anticipate its completion by May/June 2025.”

About CuraTeQ: CuraTeQ Biologics Private Limited (CuraTeQ), a subsidiary of Aurobindo Pharma Limited, is a global biopharmaceutical company headquartered in Hyderabad, India. CuraTeQ’s vision is to improve the wellbeing of patients suffering from debilitating illnesses by providing them access to high quality and cost-effective biosimilars. It is focused on developing biosimilars for the treatment of various cancers and autoimmune diseases. CuraTeQ’s pipeline consists of fourteen biosimilars, primarily targeting the immunology and oncology segments. It has end-to-end capabilities in producing a full range of products from bulk drug substance to fill-finish and packaged drug products.

Article excerpt reposted from: CNBC TV 18