Biocon Biologics Gets U.S. FDA Nod for Denosumab Biosimilars, Bosaya™ and Aukelso™
Approval for biosimilars in the U.S. market can lead to significant revenue generation, as the reference products had substantial sales.
FDA approval of two biosimilar products is a positive development for the company.
* Biocon Biologics Ltd. (BBL) has received U.S. FDA approval for Bosaya™ (denosumab-kyqq) 60 mg/mL injection and Aukelso™ (denosumab-kyqq) 120 mg/1.7 mL injection, biosimilars of Prolia® and Xgeva®. * The U.S. FDA granted provisional interchangeability designation for both BOSAYA and AUKELSO. * Bosaya™ is approved for treating postmenopausal women and men with osteoporosis, glucocorticoid-induced osteoporosis, and bone mass increase in cancer therapies. * Aukelso™ is approved for preventing skeletal-related events in multiple myeloma and bone metastases, treating giant cell tumors, and hypercalcemia of malignancy. * Clinical data showed comparable quality, safety, and efficacy to the reference products. * Denosumab had nearly $5 billion (₹41,500 crore) in U.S. sales for the period ended December 2024, with Prolia achieving $3.3 billion (₹27,300 crore) and Xgeva generating $1.6 billion (₹13,300 crore). * Shreehas Tambe, CEO & Managing Director, Biocon Biologics, said, “The FDA’s approval of Bosaya ™ and Aukelso ™ is a significant milestone in our mission to expand access to critical biologic therapies...”.
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Biocon Limited filed this with the NSE as a statutory disclosure, categorised under product launches. It is a primary document, not a recommendation, and the desk marks it high impact, which is the band that most often changes something.
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