On Wednesday, Biocon Biologics said the FDA cleared Bosaya (denosumab-kyqq) and Aukelso (denosumab-kyqq), biosimilars of Amgen’s Prolia and Xgeva, respectively. The regulator also granted provisional interchangeability for both drugs, permitting pharmacy-level substitution subject to state laws.
Treatment scope
Bosaya, a 60 mg/mL prefilled syringe for subcutaneous use, has been approved for treating postmenopausal women and men with osteoporosis at high risk of fracture, glucocorticoid-induced osteoporosis, and bone loss associated with cancer therapies.
Aukelso, a 120 mg/1.7 mL single-dose vial, is indicated for preventing skeletal-related events in patients with multiple myeloma or bone metastases, as well as for giant cell tumour of bone and hypercalcaemia of malignancy unresponsive to bisphosphonate therapy.
In the June quarter, Biocon reported a 95% year-on-year drop in net profit to Rs 31 crore. On a like-for-like basis, however, profit after tax rose 65% after adjusting for last year’s one-time gains from selling the metabolic, oncology, and critical care portfolio of its Branded Formulations India (BFI) business to Eris Lifesciences.
On Wednesday, Biocon shares closed 1.6% lower at Rs 354.40 on the BSE, taking year-to-date losses to 4%.Also read | With gold prices at record highs, are gold loan lenders a better bet for your portfolio than jewellery makers?
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