Shares of Biocon Ltd. gained almost 2% on Thursday, trading at ₹360.85, after its subsidiary Biocon Biologics Ltd. (BBL) announced a major regulatory milestone in the U.S. market.
The U.S. Food and Drug Administration (FDA) has approved Bosaya™ (denosumab-kyqq) 60 mg/mL injection and Aukelso™ (denosumab-kyqq) 120 mg/1.7 mL injection, biosimilars to the widely used Prolia® and Xgeva® drugs. Both products have also received provisional interchangeability designation, allowing substitution with their reference drugs under certain conditions, thereby improving patient access.
Bosaya™ is indicated for osteoporosis treatment in postmenopausal women and men at high fracture risk, while Aukelso™ is approved for preventing skeletal-related events in multiple myeloma and bone metastases, among other indications. Together, these approvals tap into a U.S. denosumab market worth nearly $5 billion in 2024, according to IQVIA data.
The development strengthens Biocon Biologics’ growing U.S. biosimilars portfolio and further establishes its foothold in the high-value biologics segment.
