Denosumab Biosimilars Secure FDA and EU Approvals for Osteoporosis and Cancer-Related Bone Loss

Published: 19 Feb 2025

Author: Precedence Research

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The FDA and EC approved the two biosimilars referencing denosumab, Ospomyv, and Xbryk, for different indications derived from the treatment of osteoporosis and skeletal complications from cancer. The FDA approved Ospomyv for use in all indications that are covered by their reference drugs, Prolia and Xgeva. The EC approved Obodence and Xbryk for treating the same indications held by Prolia and Xgeva. This great advancement in osteoporosis and cancer-related bone loss treatment is a very big regulatory milestone.

U.S. Key Indications for Ospomyv and Xbryk

Ospomyv:

• Osteoporosis in postmenopausal women at high risk.
• Increases bone mass in men with osteoporosis.
• Glucocorticoid-induced osteoporosis.
• Increases bone mass in men undergoing androgen deprivation therapy.
• Increases bone mass in women receiving adjuvant aromatase inhibitor therapy.

Xbryk:

• Prevent skeletal-related events from occurring in patients with multiple myeloma or bone metastases.
• Relevant also for adults and adolescents with unresectable giant cell tumors.
• Treats hypercalcemia refractory to bisphosphonate therapy.

Indications for Osteoporosis Treatment in the EU

• Obodence: Treats osteoporosis in postmenopausal women and men at high risk of fractures.
• Prostate cancer: Treats development of bone loss resulting from therapy with hormone ablation.
• Glucocorticoids long-term: Treat adults with increased fracture risk due to bone loss.
• Xbryk: Prevents skeletal-related events in adults with advanced malignancies of the bone.
• Intervention for unresectable bone tumors or those with serious surgical risks.

Clinical Validation: Phase 1 Trial Findings

The Phase 1 trial involving 300 healthy male patients approved for the evaluation of denosumab biosimilar (LY06006) against denosumab sourced from the USA and EU determined the equivalence of pharmacokinetics, pharmacodynamics, safety, and immunogenicity. The prior PK endpoints were deemed to have met the same criteria for bioequivalence as defined before, where values controlled for the bioequivalence margin of 80% to 125% agreed upon beforehand. With efficacy and safety profiles comparable to the reference products, denosumab biosimilars hence were approved. The clinical evidence and set pharmacokinetic and pharmacodynamic equivalence criteria substantiate the results of this study.

Industry Impact and Expert Perspectives

Industry leaders laud FDA and EU approvals of Ospomyv and Xbryk as a major step toward treatment accessibility and reduced healthcare costs for patients with osteoporosis and cancers related to bone loss.

Byoungin Jung, Vice President, and Regulatory Affairs Team Leader at Samsung Bioepis, talks about the need for quality-approved biosimilars to tackle a critical healthcare need and reduce the burden of skeletal fractures affecting patients' quality of life. The EU approval of a biosimilar demonstrated to have the same clinical efficacy and safety as the reference medicine is a major advance toward improving access for patients suffering from osteoporosis and cancer-related bone loss to effective treatment options.

The Future of Biosimilars in Osteoporosis and Oncology

Denosumab biosimilars represent a milestone in the acceptance of biosimilars for the treatment of osteoporosis and neoplasms with possible cost-saving and clinically efficacious attributes. The availability of major markets around the globe of Ospomyv, Xbryk, and Obodence is testimony to the growing confidence in biosimilars for treating bone-related health conditions. The expansion of biosimilar acceptance will allow healthcare providers and patients to enjoy greater treatment choices and cost savings.