- Health Canada has approved Denoza (denosumab), developed by Apotex, as a biosimilar to Prolia (denosumab)
- It is indicated for postmenopausal women and men with osteoporosis at high fracture risk, along with other approved indications of the reference biologic
- Denoza will be available in a prefilled syringe format, offering a convenient administration option
- With osteoporosis affecting ~2.3M Canadians, the approval supports improved access and expands treatment choices within the healthcare system
Takeaways:
Apotex’s Denoza biosimilar gives Canada a home‑grown denosumab option, intensifying price and tender pressure on Amgen’s Prolia in a market with 2.3M osteoporosis patients and rising biologic costs.
Prefilled syringe presentation and full Prolia‑label indications position Denoza as a plug‑and‑play alternative for high‑fracture‑risk patients, supporting payer biosimilar‑first policies and broadening access in primary and specialty care.
Source: Apotex | Image: Apotex