In addition, the US FDA granted a provisional interchangeability designation for both BOSAYA and
AUKELSO

Biocon Biologics Ltd (BBL) announced that the US Food and Drug Administration (FDA) has approved  Bosaya (denosumab-kyqq) 60 mg/mL injection for subcutaneous use in a single-dose prefilled syringe (PFS), and Aukelso (denosumab-kyqq) 120 mg/1.7 mL (70 mg/mL) injection for subcutaneous use in a single-dose vial, biosimilars of Prolia and Xgeva, respectively.

In addition, the US FDA granted a provisional interchangeability designation for both BOSAYA and
AUKELSO.

Shreehas Tambe, CEO and 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 ith 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, 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, 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 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.