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As on : 18-Sep-2025

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18-Sep-2025 11:26

Biocon gains after arm gets USFDA nod for two denosumab biosimilars

Bosaya, a 60 mg/mL prefilled syringe for subcutaneous use, has been approved for the treatment of postmenopausal women and men with osteoporosis at high risk of fracture, glucocorticoid-induced osteoporosis, and bone loss caused by cancer therapies. Aukelso, a 120 mg/1.7 mL single-dose vial, has been approved for the prevention of skeletal-related events in patients with multiple myeloma or bone metastases, as well as for the treatment of giant cell tumor of bone and hypercalcemia of malignancy refractory to bisphosphonate therapy.

The USFDA has also granted provisional interchangeability designation for both products, enabling pharmacy-level substitution subject to state regulations. Clinical studies confirmed comparable safety, efficacy, and quality with the reference drugs.

According to IQVIA, denosumab generated nearly $5 billion in US sales in 2024, with Prolia accounting for $3.3 billion and Xgeva for $1.6 billion.

Biocon Biologics CEO & MD Shreehas Tambe said the approvals expand the company's oncology and bone health portfolio and 'support sustainable healthcare systems by offering more affordable treatment options.'

Biocon is a global biopharma company dedicated to improving affordable access to therapies for chronic conditions such as diabetes, cancer, and autoimmune diseases.

In its latest financial results, Biocon reported a 95.2% decline in consolidated net profit to Rs 31.40 crore despite a 15.8% jump in net sales to Rs 3,910.10 crore in Q1 FY26 compared to Q1 FY25.

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