Biocon Biologics has announced that the US Food and Drug Administration (FDA) has approved Bosaya 60 mg/mL injection for subcutaneous use and Aukelso 120 mg/1.7 mL (70 mg/mL) injection, biosimilars of Prolia and Xgeva, respectively.
In addition, the US FDA granted a provisional interchangeability designation for both BOSAYA and AUKELSO.
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."
"With Bosaya, we are proud to offer a more affordable treatment option for patients with osteoporosis and with Aukelso, we are further expanding our oncology care portfolio."
"This achievement underscores our scientific and regulatory capabilities and reinforces our commitment to delivering high-quality biosimilars that support sustainable healthcare systems and improve patient outcomes."
BOSAYA is approved for the treatment of postmenopausal women with osteoporosis at high risk for fracture and to increase bone mass in men with osteoporosis at high risk for fracture.
It is also approved for the treatment of glucocorticoid-induced osteoporosis in men and women at high risk for fracture, to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer and to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.
AUKELSO is approved for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumours.
It is also approved to treat adults and skeletally mature adolescents with giant cell tumour of bones that are unresectable or where surgical resection is likely to result in severe morbidity and to treat hypercalcaemia of malignancy refractory to bisphosphonate therapy.
Clinical data showed that both biosimilars demonstrated comparable quality, safety and efficacy to the reference product.
BOSAYA is approved with the same Risk Evaluation and Mitigation Strategy (REMS) plan as PROLIA to likewise inform healthcare providers and patients of the risks of severe hypocalcaemia in patients with advanced chronic kidney disease (CKD) associated with BOSAYA.
According to IQVIA National Sales Perspectives Data, denosumab had nearly $5bn in US sales for the period ending December 2024, with PROLIA achieving $3.3bn and XGEVA generating $1.6bn.