Biocon Biologics, a fully integrated global biosimilars company and subsidiary of Biocon, has reached a settlement and license agreement with Amgen, clearing the path for the commercialisation 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.

The settlement resolves the pending patent litigation between the two companies at the United States District Court for the District of New Jersey. The agreement enables Biocon Biologics to launch Bosaya and Aukelso in the US 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 US Food and Drug Administration (FDA) had approved Bosaya and Aukelso in September 2025. In addition, the US FDA granted a provisional interchangeability designation for both biosimilars.

To date, Biocon Biologics has commercialised 10 biosimilars globally and has a robust pipeline of 20 biosimilar assets across diabetology, oncology, immunology, ophthalmology, bone health and other non-communicable diseases.