Aurobindo Pharma’s subsidiary, CuraTeQ Biologics, Reports Positive Trial Results for Osteoporosis Drug BP16

Aurobindo Pharma’s subsidiary, CuraTeQ Biologics, has announced successful clinical trial results for its investigational biosimilar BP16, designed to replicate the bone health medicine denosumab. The drug is intended to treat various bone-related conditions, including osteoporosis and bone complications arising from cancer and its treatments.

The bioequivalence trial involved 204 healthy volunteers from Australia and New Zealand, comparing BP16 with Prolia, the reference denosumab product marketed in the European Union and the United States.

Therapeutic Applications of BP16

BP16 targets and blocks the RANKL protein, which plays a central role in bone tissue breakdown. This mechanism makes the drug useful for treating:

• Osteoporosis in postmenopausal women
• Bone loss from cancer metastasis
• Bone weakening due to cancer therapy

The company sees this biosimilar as a cost-effective alternative to existing denosumab products, potentially improving access for patients worldwide.

Bioequivalence and Clinical Results

Arpitkumar Prajapati, Head of Clinical Sciences at CuraTeQ Biologics, told CNBC TV18: “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%.”

He added that: “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.”

Aurobindo Pharma Share Price Performance

As of the end of trading on April 9, 2025, Aurobindo Pharma’s shares closed at ₹1,055.00 on the NSE, registering a 3.83% decline. The Deliverable/Traded Quantity stood at 32.67%, and the company’s market capitalisation was ₹61,274.57 crore.

Conclusion

The trial success of BP16 marks a significant milestone for CuraTeQ Biologics and Aurobindo Pharma in the biologics space. With the study confirming biosimilarity with existing denosumab products, BP16 could soon offer patients a more affordable therapeutic option for treating serious bone-related conditions.

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