Biocon Biologics Ltd. (BBL), a global leader in biosimilars and a subsidiary of Biocon Ltd. (BSE: 532523, NSE: BIOCON), has achieved a significant 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 of the well-known Prolia® and Xgeva® drugs. Both products have also been granted a provisional interchangeability designation, which allows them to be substituted for their reference products under certain conditions, enhancing accessibility for patients.
Bosaya™ is approved for the treatment of osteoporosis in postmenopausal women and men at high risk of fractures, including those with glucocorticoid-induced osteoporosis, men receiving androgen deprivation therapy for non-metastatic prostate cancer, and women undergoing adjuvant aromatase inhibitor therapy for breast cancer. The product is supplied in a 60 mg/mL prefilled syringe (PFS) for subcutaneous use and follows the same Risk Evaluation and Mitigation Strategy (REMS) as Prolia®, ensuring healthcare providers and patients are informed about the potential risk of severe hypocalcemia in patients with advanced chronic kidney disease, including those on dialysis.
Aukelso™ is approved to prevent skeletal-related events in patients with multiple myeloma and bone metastases from solid tumors. It is also indicated for adults and skeletally mature adolescents with unresectable giant cell tumor of bone and for the treatment of hypercalcemia of malignancy that is refractory to bisphosphonate therapy. This biosimilar comes in a 120 mg/1.7 mL single-dose vial for subcutaneous injection.
Clinical studies have demonstrated that both Bosaya™ and Aukelso™ exhibit comparable quality, safety, and efficacy to their respective reference products. According to IQVIA National Sales Perspectives Data, denosumab achieved nearly $5 billion in U.S. sales in 2024, with Prolia® contributing $3.3 billion and Xgeva® generating $1.6 billion.
