Shots:
- The US FDA has approved & granted provisional interchangeability designation to Aukelso (70mg/mL, SC, single-dose vial) & Bosaya (60mg/mL, SC, PFS), biosimilar versions of Amgen’s Xgeva & Prolia (denosumab)
- Clinical data showed both biosimilars matched the reference product in quality, safety & efficacy, plus Bosaya was approved with Prolia’s REMS to inform about sev. hypocalcemia risk in advanced CKD, incl. dialysis
- Denosumab is a mAb that works by targeting Receptor Activator of Nuclear Factor Kappa-B Ligand (RANKL), which regulates bone metabolism & osteoclast formation
Ref: Biocon| Image: Biocon| Press Release
Related News:- Biocon Biologics’ Kirsty (Biosimilar, NovoLog) Secures the US FDA’s Approval
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com
