Posted by Michael Wonder on 19 Sep 2025
Biocon Biologics receives US FDA approval for Bosaya and Aukelso, denosumab biosimilars
17 September 2025 - Biocon Biologics today announced that the US FDA has approved Bosaya (denosumab-kyqq) 60 mg/mL injection for subcutaneous use in a single dose pre-filled syringe 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 provisional interchangeability designation for both Bosaya and Aukelso.
