Organon launches denosumab biosimilars in Canada

• BILDYOS and TUZEMTY biosimilars to Prolia and Xgeva are now available in Canada for all approved indications.
• The launch expands Organon’s biosimilars portfolio in Canada across five therapeutic areas and aims to improve treatment access and reduce healthcare costs.
• Organon and partner Shanghai Henlius Biotech stated the products will broaden options for osteoporosis and cancer-related bone conditions affecting millions of patients.

Organon (NYSE:OGN) and Shanghai Henlius Biotech, made BILDYOS (denosumab injection) 60 mg/1 mL and TUZEMTY (denosumab injection) 120 mg/1.7 mL available in Canada.

The products are biosimilars to Amgen’s Prolia and Xgeva and treat osteoporosis as well as bone events linked to cancer.

“The approvals represent an important step toward helping broaden access to bone-care treatments in Canada,” said Dominic Bégin, President and Managing Director at Organon Canada.

The launch adds the two denosumab biosimilars to Organon’s existing portfolio in Canada, which already spans five therapeutic areas, including oncology.

Organon stated the move will increase access to cost-effective treatments.

Following the announcement, Organon's share price was unchanged.

The companies signed a license and supply agreement in 2022 that grants Organon exclusive commercialization rights to several Henlius biosimilars outside China.

Organon continues to expand its focus on women’s health and biosimilars as part of a broader strategy to offer more treatment choices in key markets.