Dr. Reddy’s Laboratories has received approval from the European Commission for its denosumab biosimilar, used in the treatment of osteoporosis and cancer-related bone conditions. The authorization covers all 27 European Union member states, as well as Iceland, Liechtenstein and Norway.
The biosimilar is approved for reducing fracture risk in postmenopausal women with osteoporosis, increasing bone mass in men at high fracture risk, and preventing skeletal-related events in patients with bone metastases from solid tumors.
The approval marks a significant milestone in Dr. Reddy’s biosimilar portfolio and strengthens its presence in the European market. The company plans a phased launch across Europe, expanding access to advanced bone health therapy at potentially lower treatment costs.
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