Biocon Biologics has secured FDA approval for its denosumab biosimilars, Bosaya™ and Aukelso™, referencing Prolia® and Xgeva® respectively. These approvals mark a significant step in expanding access to critical biologic therapies, offering more affordable treatment options for osteoporosis and expanding the company’s oncology portfolio. The FDA also granted provisional interchangeability designation for both biosimilars.
Denosumab Biosimilars Approved
Biocon Biologics Ltd. (BBL) announced that 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. These biosimilars reference Prolia® and Xgeva® respectively, and are indicated for subcutaneous use. The FDA granted provisional interchangeability designation for both BOSAYA and AUKELSO.
Management Commentary
Shreehas Tambe, CEO & Managing Director of Biocon Biologics, stated that these approvals represent a significant milestone in expanding access to critical biologic therapies, offering an affordable option for osteoporosis patients with Bosaya™, and further expanding their oncology care portfolio with Aukelso™.
Indications and Usage
BOSAYA is approved for treating postmenopausal women and men with osteoporosis at high risk for fracture, glucocorticoid-induced osteoporosis, increasing bone mass in men receiving androgen deprivation therapy, and women receiving adjuvant aromatase inhibitor therapy.
AUKELSO is approved for preventing skeletal-related events in patients with multiple myeloma and bone metastases from solid tumors, treating adults and skeletally mature adolescents with giant cell tumor of bone, and treating hypercalcemia of malignancy.
Clinical Data and Safety
Clinical data demonstrated comparable quality, safety, and efficacy to the reference products. BOSAYA is approved with the same Risk Evaluation and Mitigation Strategy (REMS) plan as PROLIA to inform healthcare providers and patients about the risks of severe hypocalcemia in patients with advanced chronic kidney disease.
Market Overview
As of December 2024, denosumab had nearly $5 billion in U.S. sales, with PROLIA achieving $3.3 billion and XGEVA generating $1.6 billion, according to IQVIA National Sales Perspectives Data.
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