Apotex announced Health Canada’s approval of DENOZA™ (denosumab injection), a biosimilar referencing Amgen’s Prolia®, for the treatment of osteoporosis in postmenopausal women at increased risk of fracture. The milestone expands access to one of the most widely used biologic therapies targeting bone loss in Canada.
Denosumab is a fully human monoclonal antibody that binds to the RANK ligand (RANKL), a critical regulator of osteoclast formation and activity. By inhibiting RANKL, denosumab reduces bone resorption and increases bone mass and strength. Health Canada’s authorization of DENOZA™ was supported by analytical and clinical data confirming comparable efficacy, safety, and immunogenicity to the reference biologic.
The approval advances Apotex’s biosimilar portfolio and reinforces ongoing efforts to enhance affordability and sustainability within biologic treatment markets. Biosimilars such as DENOZA™ are designed to provide equivalent therapeutic outcomes at lower cost, supporting healthcare system efficiency and improving patient access to essential therapies.
Osteoporosis affects nearly two million Canadians and remains a significant driver of mortality and morbidity in aging populations. With DENOZA™, Apotex strengthens its position in biologics manufacturing and expands therapeutic options available through healthcare providers and pharmacies nationwide.
The company noted that the introduction of DENOZA™ reflects its long-term strategy to increase biosimilar adoption and contribute to global health system resiliency through advanced biologic development.
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