Biosimilar Denosumab of Alkem (Denuril) shows Comparable Efficacy in Treating Postmenopausal Osteoporosis in Indian Women

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:

• The safety profiles of Denuril and Innovator were found to be comparable, with no significant differences in adverse events.

This study highlights the potential of Denuril to improve the quality of life for millions of osteoporosis patients in India. Priced at Rs 8,625/- per injection. Denuril offers an affordable and effective alternative to Innovator, showing equivalence in efficacy, safety, and pharmacokinetics for osteoporosis management.

 BMD: Bone Mineral Density

Adapted from:

1) Paul T, Garg B, Kapoor N, Patil V, Kachnerkar N, Shembalkar J, Purohit S, Maheshwari S, Maheshwari S, Yadav A, Cherian JJ, Agrawal A, Basu K, Tripathy SK, Pongde AB, Goni V, Markade P, Makane A, Tiwaskar M, Cherian KE, Rane Y, Shahavi V, Poojary V, Somani R, Gondane A, Aiwale A, Pawar D, Pawar R, Sharma A. A Prospective, Active-controlled, Randomized, Double-blind, Multicenter, Phase III Study to Compare the Safety and Efficacy of Biosimilar Denosumab vs Reference Denosumab in the Treatment of Postmenopausal Osteoporosis. J Assoc Physicians India. 2025 Jan;73(1):e8-e13. doi: 10.59556/japi.73.0772. PMID: 39893524.