Accord Healthcare Launches Denosumab Biosimilars for Bone Health
On December 3, 2025, Accord Healthcare announced the launch of Osvyrti (Denosumab), a biosimilar to Prolia® (Amgen), and Jubereq (Denosumab), a biosimilar to Xgeva® (Amgen). This development follows the expiration of the reference product's patent on November 27, 2025. Both biosimilars received approval from the European Medicines Agency (EMA) earlier in September 2025 after showing significant similarity to their reference products in clinical studies.
With a growing focus on enhancing patient accessibility to high-quality, affordable medications, Osvyrti and Jubereq mark Accord's second and third entries in the bone health portfolio. They are aimed at addressing a substantial clinical need in managing bone health conditions.
Osvyrti is available in a pre-filled syringe of 60 mg and is indicated for:
1. The treatment of osteoporosis in postmenopausal women and men at increased risk of fractures.
2. The management of bone loss associated with hormone ablation in men with prostate cancer, who are also at heightened fracture risk.
3. Addressing bone loss resulting from long-term systemic glucocorticoid therapy in adult patients with increased fracture risks.
Jubereq comes in 120 mg vials and is indicated for:
1. The prevention of skeletal-related events (like pathological fractures) in adults with advanced malignancies that impact the bones.
2. The treatment of adults and skeletally mature adolescents with unresectable giant cell tumor of the bone or those at high risk of severe morbidity from surgical resection.
"Both Osvyrti and Jubereq have received approval for various bone-related indications, including osteoporosis management and bone loss due to specific cancers," commented Paul Tredwell, Global CEO of Accord Healthcare. "These biosimilars hold the potential to provide numerous patients with treatment alternatives, thereby reducing cost barriers to proven therapies. The launch of Osvyrti and Jubereq represents a significant advancement in expanding access to biosimilars, aligning with our strategic goal to introduce 20 biosimilars by 2030."
Osteoporosis is a chronic condition characterized by reduced bone mass and deterioration of bone structure, increasing fracture risk. More than 200 million people globally are affected, with around one in three women and one in five men over 50 expected to experience osteoporosis-related fractures in their lifetime. As the global population ages, the prevalence and economic burden of osteoporosis are set to grow, further straining healthcare systems.
Osvyrti demonstrated a comparable increase in bone mineral density (BMD) in the lumbar spine after 12 months, with profiles in pharmacokinetics, safety, and immunogenicity showing equivalence to the reference Denosumab. The low incidence of anti-drug antibodies (≤ 1.6%) across treatment groups with no observed neutralizing antibodies highlights the biosimilar's reliability as an alternative.
Jubereq achieved bioequivalence to the reference product, exhibiting no clinically significant differences in effectiveness or safety profiles. Patients with metastatic prostate cancer after a skeletal-related event (SRE) reported notable improvements in quality of life metrics following treatment with Jubereq, showcasing its long-lasting effects.
With the introduction of Osvyrti and Jubereq, patients gain enhanced access to effective treatments for osteoporosis and bone health management. Accord Healthcare remains steadfast in its mission to collaborate with healthcare professionals and systems to improve patient outcomes and generate value across various therapeutic areas, including oncology, bone health, and autoimmune diseases. The launch of these two biosimilars signifies a promising step in making vital medications more accessible to patients who've traditionally faced barriers due to costs.
With a growing focus on enhancing patient accessibility to high-quality, affordable medications, Osvyrti and Jubereq mark Accord's second and third entries in the bone health portfolio. They are aimed at addressing a substantial clinical need in managing bone health conditions.
Indications and Benefits
Osvyrti is available in a pre-filled syringe of 60 mg and is indicated for:
1. The treatment of osteoporosis in postmenopausal women and men at increased risk of fractures.
2. The management of bone loss associated with hormone ablation in men with prostate cancer, who are also at heightened fracture risk.
3. Addressing bone loss resulting from long-term systemic glucocorticoid therapy in adult patients with increased fracture risks.
Jubereq comes in 120 mg vials and is indicated for:
1. The prevention of skeletal-related events (like pathological fractures) in adults with advanced malignancies that impact the bones.
2. The treatment of adults and skeletally mature adolescents with unresectable giant cell tumor of the bone or those at high risk of severe morbidity from surgical resection.
Commitment to Osteoporosis Care
"Both Osvyrti and Jubereq have received approval for various bone-related indications, including osteoporosis management and bone loss due to specific cancers," commented Paul Tredwell, Global CEO of Accord Healthcare. "These biosimilars hold the potential to provide numerous patients with treatment alternatives, thereby reducing cost barriers to proven therapies. The launch of Osvyrti and Jubereq represents a significant advancement in expanding access to biosimilars, aligning with our strategic goal to introduce 20 biosimilars by 2030."
Osteoporosis: A Global Health Challenge
Osteoporosis is a chronic condition characterized by reduced bone mass and deterioration of bone structure, increasing fracture risk. More than 200 million people globally are affected, with around one in three women and one in five men over 50 expected to experience osteoporosis-related fractures in their lifetime. As the global population ages, the prevalence and economic burden of osteoporosis are set to grow, further straining healthcare systems.
Clinical Study Insights
Osvyrti demonstrated a comparable increase in bone mineral density (BMD) in the lumbar spine after 12 months, with profiles in pharmacokinetics, safety, and immunogenicity showing equivalence to the reference Denosumab. The low incidence of anti-drug antibodies (≤ 1.6%) across treatment groups with no observed neutralizing antibodies highlights the biosimilar's reliability as an alternative.
Jubereq achieved bioequivalence to the reference product, exhibiting no clinically significant differences in effectiveness or safety profiles. Patients with metastatic prostate cancer after a skeletal-related event (SRE) reported notable improvements in quality of life metrics following treatment with Jubereq, showcasing its long-lasting effects.
Conclusion: A Step Forward
With the introduction of Osvyrti and Jubereq, patients gain enhanced access to effective treatments for osteoporosis and bone health management. Accord Healthcare remains steadfast in its mission to collaborate with healthcare professionals and systems to improve patient outcomes and generate value across various therapeutic areas, including oncology, bone health, and autoimmune diseases. The launch of these two biosimilars signifies a promising step in making vital medications more accessible to patients who've traditionally faced barriers due to costs.
Topics Health）
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