Biocon Biologics, Amgen strike settlement, clear path for Bosaya, Aukelso in US
Bengaluru: Biocon Biologics Ltd., a fully integrated global biosimilars company and subsidiary of Biocon Ltd., has announced a settlement and license agreement with Amgen Inc. that clears the path for the commercialization of Bosaya (denosumab-kyqq) and Aukelso (denosumab-kyqq) in the United States.
Bosaya 60 mg/mL injection in a single-dose prefilled syringe (PFS) and Aukelso 120 mg/1.7 mL (70 mg/mL injection for subcutaneous use in a single-dose vial, are biosimilars to Amgen’s Prolia and Xgeva, respectively.
These products are used in the treatment of osteoporosis and cancer-related bone conditions. 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, glucocorticoidinduced 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 toresult in severe morbidity, and to treat hypercalcemia 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 hypocalcemia in patients with advanced chronic kidney disease (CKD), including dialysis-dependent patients, associated with BOSAYA.
Biocon Biologics and Amgen executed the settlement agreement to resolve the pending patent litigation at the United States District Court for the District of New Jersey. The agreement enables Biocon Biologics to launch BOSAYA and AUKELSO in the U.S. from October 1, 2025. The other terms of the settlement remain confidential.
Shreehas Tambe, CEO & Managing Director, Biocon Biologics, said, “This settlement paves the way for Biocon Biologics to bring our high-quality denosumab biosimilars, Aukelso and Bosaya, to patients and healthcare providers in the United States. These therapies will not only strengthen our oncology portfolio but also mark our entry into the bone health space—an important step as we continue to broaden access to life-changing biologics for patients across therapeutic areas. By expanding access to advanced biologic medicines, we are reaffirming our role as a global biosimilar leader.” The U.S. Food and Drug Administration (FDA) had approved BOSAYA and AUKELSO in September 2025. In addition, the U.S. FDA granted provisional interchangeability designation for both BOSAYA and AUKELSO.
