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Aurobindo Pharma arm CuraTeQ Biologics completes successful Phase 1 Pharmacokinetics study of bone drug

Written By : Ruchika Sharma |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2025-04-10T11:56:00+05:30  |  Updated On 10 April 2025 11:56 AM IST
Aurobindo Pharma arm CuraTeQ Biologics completes successful Phase 1 Pharmacokinetics study of bone drug
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Denosumab works by specifically targeting the RANK ligand (RANKL), a critical protein in the lifecycle of osteoclasts, the cells that break down bone.

Hyderabad: CuraTeQ Biologics Private Limited, a wholly owned subsidiary of Aurobindo Pharma Ltd, has announced that its denosumab biosimilar, BP16, has successfully met the primary endpoints in a comprehensive pharmacokinetic (PK) and pharmacodynamic (PD) study.

This study enrolled a total of 204 healthy volunteers into three groups to compare BP16 with the reference products, Prolia, obtained from both the EU and US markets.

Dr. Arpitkumar Prajapati, Head of Clinical Sciences at CuraTeQ Biologics, stated, “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 percent. 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.”

Denosumab works by specifically targeting the RANK ligand (RANKL), a critical protein in the lifecycle of osteoclasts, the cells that break down bone. Denosumab's ability to inhibit RANKL makes it highly effective in treating conditions linked to bone loss, such as osteoporosis in postmenopausal women, bone metastases from cancers, and cancer treatment-related bone health issues.

Read also: Aurobindo Pharma arm terminates agreement with Hilleman Labs Singapore for pentavalent vaccine

“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," said Dr. Disha Dadke, Head of R&D and Regulatory Sciences at CuraTeQ Biologics. "We aim to submit a Marketing Authorization application to CHMP/EMA in the third quarter of this fiscal year.”

Read also: Aurobindo Pharma arm gets European Commission authorization to market Dyrupeg in EU

curateq biologicscurateq biologics newsaurobindo pharmadenosumabproliaxgeva
Ruchika Sharma
Ruchika Sharma

    Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

    Dr. Kamal Kant Kohli
    Dr. Kamal Kant Kohli

    Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751

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