Shots:
- Biocon Biologics & Amgen have entered into a settlement & license agreement, allowing the US launch of Bosaya (60mg/mL, SC, PFS) & Aukelso (70mg/mL, SC, single-dose vial), provisional interchangeable biosimilars to Prolia & Xgeva (denosumab) by Oct 1, 2025
- 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 RANKL, which regulates bone metabolism & osteoclast formation
Ref: Biocon Biologics| Image: Biocon Biologics| Press Release
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