The Department of Endocrinology, 
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.
- Professor, Department of Endocrinology, Christian Medical College, Vellore, Tamil Nadu, India.
- Professor, Department of Orthopedics, All India Institute of Medical Sciences, New Delhi, India.
- Professor, Department of Endocrinology, Diabetes and Metabolism, Christian Medical College, Vellore, Tamil Nadu, India.
- Consultant Orthopedic Surgeon, Life Point Hospital, Pune, Maharashtra, India.
- Director and Chief Orthopedic Surgeon, Ishwar Institute of Healthcare, Aurangabad, Maharashtra, India.
- Consultant Endocrinologist, Getwell Hospital and Research Institute, Nagpur, Maharashtra, India.
- Consultant Orthopedic Surgeon, Sanjivani Super Specialty Hospitals Pvt. Ltd., Ahmedabad, Gujarat, India.
- Senior Consultant Orthopedic Surgeon, Medilink Hospital and Research Centre, Ahmedabad, Gujarat, India.
- Clinical Research Coordinator, Medilink Hospital and Research Centre, Ahmedabad, Gujarat, India.
- Consultant Orthopedic Surgeon, Om Surgical Center and Maternity Home, Varanasi, Uttar Pradesh, India.
- Professor, Department of Orthopedics, St. Johns Medical College Hospital, Bengaluru, Karnataka, India.
- Consultant Orthopedic Surgeon, KRM Hospital and Research Center, Lucknow, Uttar Pradesh, India.
- Associate Professor, Department of General Medicine, Medical College and Hospital, Kolkata, West Bengal, India.
- Professor, Department of Orthopedics, All India Institute of Medical Sciences, Bhubaneswar, Odisha, India.
- Orthopedic and Joint Replacement Surgeon, Shree Hospital and Critical Care Center, Nagpur, Maharashtra, India.
- Professor, Department of Orthopedic Surgery, Postgraduate Institute of Medical Education and Research, Chandigarh, India.
- Director and Chief Orthopedic Surgeon, Ishwar Institute of Healthcare, Padegaon, Aurangabad, Maharashtra, India.
- Director, Ishwar Institute of Healthcare, Padegaon, Aurangabad, Maharashtra, India.
- Consultant Physician and Diabetologist, Shilpa Medical Research Centre, Mumbai, Maharashtra, India.
- Project Manager, Clinical Research Division, Alkem Laboratories Ltd., Mumbai, Maharashtra, India.
- Head, Clinical Research Division, Alkem Laboratories Ltd., Mumbai, Maharashtra, India.
- Drug Safety Physician, Pharmacovigilance Division, Alkem Laboratories Ltd., Mumbai, Maharashtra, India.
- Head, Pharmacovigilance Division, Alkem Laboratories Ltd., Mumbai, Maharashtra, India.
- Medical Advisor, Medical Affairs Division, Alkem Laboratories Ltd., Mumbai, Maharashtra, India.
- Therapeutic Lead, Medical Affairs Division, Alkem Laboratories Ltd., Mumbai, Maharashtra, India, Corresponding Author.
- Head, Medical Affairs Division, Alkem Laboratories Ltd., Mumbai, Maharashtra, India.
- President and Chief Medical Officer, Medical Division, Alkem Laboratories Ltd., Mumbai, Maharashtra, India.
The Journal of the Association of Physicians of India Vol. 73 · Issue 1 · pp. e8-e13
PMID 39893524 DOI 10.59556/japi.73.0772
Cite This Article
Thomas Paul, Bhavuk Garg, Nitin Kapoor, Vishal Patil, Nilesh Kachnerkar, Jayashri Shembalkar, Sharad Purohit, Sunil Maheshwari, Surabhi Maheshwari, Awadhesh Yadav, Joe Joseph Cherian, Anubhav Agrawal, Kaushik Basu, Sujit Kumar Tripathy, Ashish B Pongde, Vijay Goni, Pravin Markade, Abhimanyu Makane, Mangesh Tiwaskar, Kripa Elizabeth Cherian, Yogesh Rane, Vinayak Shahavi, Vivek Poojary, Rahul Somani, Ajitkumar Gondane, Amol Aiwale, Dattatray Pawar, Roshan Pawar, Akhilesh Sharma. 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. The Journal of the Association of Physicians of India. 2025;73(1):e8-e13. doi:10.59556/japi.73.0772
Abstract
OBJECTIVE: Denosumab, a human monoclonal antibody that exhibits strong affinity and specificity for the receptor activator of nuclear factor-kappa B ligand (RANK-L), is essential in regulating bone turnover. Its inhibition of RANK-L decreases bone resorption by preventing the development, function, and survival of osteoclasts. The objective of the study was to evaluate and compare the efficacy and safety of biosimilar denosumab with the reference product, Prolia (denosumab), in Indian women suffering from postmenopausal osteoporosis.
METHODS: This phase III study was a prospective, active-controlled, randomized, double-blind trial that included postmenopausal women diagnosed with osteoporosis. Participants were randomly allocated in a 2:1 ratio to receive either the biosimilar denosumab (Treatment A) or the reference denosumab (Prolia®; Treatment B). All participants also received daily supplementation of 500 international units (IU) of vitamin D3 and 1000 mg calcium. The primary outcomes measured were the bone mineral density (BMD) percentage change at the lumbar spine and the neck of femur, while the secondary endpoint assessed changes in biomarkers from baseline at months 6 and 12.
RESULTS: The lumbar spine BMD percentage change for group A vs group B from baseline to month 6 was 5.69 ± 0.88 ( < 0.0001) vs 5.08 ± 1.19 ( < 0.0001), and at 12 months was 7.26 ± 1.05 ( < 0.0001) vs 7.31 ± 1.40 ( < 0.0001), demonstrating equivalent efficacy. Both treatment groups showed statistically significant improvement in femoral neck BMD at 12 months. No statistically significant difference was noted in the ln-transformed primary pharmacokinetic parameters, including C-max, AUC0-120d, and AUC0-∞.
CONCLUSION: Biosimilar denosumab was comparable to reference denosumab with respect to its efficacy, safety, pharmacokinetics (PK), pharmacodynamics, and immunogenicity in women with postmenopausal osteoporosis. Thus, biosimilar denosumab is expected to improve the quality of life in osteoporotic patients at affordable prices.
Keywords
- Humans
- Denosumab
- Female
- Double-Blind Method
- Osteoporosis
- Postmenopausal
- Biosimilar Pharmaceuticals
- Middle Aged
- Bone Density Conservation Agents
- Bone Density
- Prospective Studies
- Aged
- Treatment Outcome
- India
