Biosimilar Denosumab of Alkem (Denuril) shows Comparable Efficacy in Treating Postmenopausal Osteoporosis in Indian Women
Written By : Dr. Nandita Mohan
Published On 2025-04-12 06:49 GMT | Update On 2025-04-12 07:23 GMT
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Biosimilar denosumab of Alkem (Denuril) showed comparable efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity to the innovator denosumab in women with postmenopausal osteoporosis, concluded in a recent study.
Published in the January 2025 issue of Journal of the Association of Physicians of India.
This Phase III randomized study included 177 osteoporotic postmenopausal women of 50–80 years age in a 2:1 ratio—116 to Denuril 61 to innovator denosumab. All received vitamin D3 (500 IU) and calcium (1000 mg) daily, with 60 mg injections every 6 months. The primary outcome was Bone Mineral Density change at the lumbar spine and femoral neck; the secondary outcome was changes in biomarkers.
Some of the key results from the study are:
Efficacy in Bone Mineral Density (BMD):
- At month 12, the increases were 7.26% in biosimilar group and 7.31% in the reference group.
- Femoral Neck Bone Mineral Density: The femoral neck BMD increased from 2.71% at 6 months to 4.21% at 12 months with Denuril, compared to 2.20% at 6 months and 4.36% at 12 months with innovator denosumab.
Safety:
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