Biocon arm receives USFDA approval for osteoporosis, skeletal-related drugs; Here are the details

Biocon Ltd on Wednesday, September 17, said that its subsidiary Biocon Biologics received approval from the US Food and Drug Administration (USFDA) for two denosumab biosimilars, Bosaya and Aukelso.

While Bosaya will be available in a 60 mg/mL injection for subcutaneous use in a single-dose prefilled syringe, Aukelso will be available as a 120 mg/1.7 mL (70 mg/mL) injection for subcutaneous use in a single-dose vial. Both are denosumab biosimilars of Prolia and Xgeva, respectively, Biocon said in a regulatory filing.

Furthermore, the USFDA granted provisional interchangeability designation for both Bosaya and Aukelos.

Bosay has been indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture. Furthermore, it will be used to increase bone mass in men with osteoporosis at high risk for fracture, glucocorticoid-induced osteoporosis in men and women at high risk for fracture.

It will also be used in treatment 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, it added.

On the other hand, Aukelos has been approved for “the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors, to treat adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity, and to treat hypercalcemia of malignancy refractory to bisphosphonate therapy.”

During the period ending December 2024, Denosumab had nearly $5 billion in sales in the US, with Prolia generating $3.3 billion and Xgeva achieving $1.6 billion, according to IQVIA National Sales Perspectives data.

Commenting on the development, Shreehas Tambe, CEO & Managing Director, Biocon Biologic, 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,” Tambe added.

Shares of Biocon closed 1.60% lower at ₹354.45 apiece on the National Stock Exchange (NSE) on Wednesday. However, the announcement was made after the market closed.

The pharmaceutical company has a total market capitalisation of ₹47,388.68 crore, as of September 17, 2025, according to data on the NSE.