#London #United Kingdom #Accord Healthcare #OSVYRTI #Jubereq

Accord Healthcare Unveils Two New Biosimilars for Bone Health

Accord Healthcare has announced the launch of two significant biosimilars aimed at improving patient access to effective treatments for bone health conditions: Osvyrti (denosumab), a biosimilar to Prolia® (Amgen), and Jubereq (denosumab), a biosimilar to Xgeva® (Amgen). This move comes after the patent expiration of Prolia, scheduled for November 27, 2025. The European Medicines Agency (EMA) approved both products in September 2025, confirming their high similarity to their reference products through rigorous comparative studies.

Importance of Biosimilars in Healthcare

The introduction of Osvyrti and Jubereq represents Accord Healthcare's second foray into the biosimilar market, significantly enhancing their portfolio focused on bone health. With a strong emphasis on improving access to high-quality and cost-effective medications, these new products are strategically aligned with the company's mission to address urgent clinical needs in the healthcare sector. Paul Tredwell, Global CEO of Accord Healthcare, expressed enthusiasm about these new biosimilars, highlighting their potential to offer alternative treatment options that alleviate the financial burden on patients while supporting healthcare providers.

Indications for Osvyrti and Jubereq

Osvyrti is designed for several critical indications:
1. Osteoporosis Treatment: Osvyrti is indicated for managing osteoporosis in postmenopausal women and men at risk of fractures.
2. Bone Loss due to Hormonal Ablation: It also helps treat bone loss connected to hormonal ablation in men undergoing prostate cancer treatment.
3. Long-term Glucocorticoid Therapy: Osvyrti is used for treating bone loss in adults subjected to long-term glucocorticoid therapy, particularly those at elevated fracture risk.

Jubereq is indicated for:
1. Bone Complications Prevention: It prevents skeletal-related events (SREs) such as pathological fractures or spinal cord compression in adults with advanced malignant tumors affecting the bone.
2. Treatment of Giant Cell Tumors: Jubereq is also applicable for adults and adolescents with unresectable giant cell tumors of the bone, particularly when surgical resection could lead to significant morbidity.

Tackling Osteoporosis Burden

Osteoporosis is a chronic disease characterized by reduced bone mass and deterioration of bone structure, leading to a higher risk of fractures. It currently affects over 200 million people globally, with a substantial portion of individuals over 50 experiencing osteoporotic fractures in their lifetime. As the population ages, the prevalence and economic burden of osteoporosis are projected to rise, placing further strain on healthcare systems worldwide. Accord Healthcare's introduction of Osvyrti and Jubereq aims to meet this pressing need, providing healthcare providers with effective treatment options.

Clinical Data Supporting Efficacy

Osvyrti demonstrates comparable increases in bone mineral density (BMD) in the lumbar spine over 12 months (with rates at 6.25% for Osvyrti vs. 6.36% for Prolia) alongside similar pharmacokinetic, pharmacodynamic, safety, and immunogenicity profiles. Only a minor incidence of anti-drug antibodies was reported (≤1.6%), with no neutralizing antibodies observed.

Jubereq has proven bioequivalence to its reference product, showing no clinically significant differences in efficacy, safety, pharmacokinetics, or immunogenicity. Notably, patients with metastatic prostate cancer reported substantial quality of life improvements after SREs when treated with Jubereq, along with superior prevention of bone complications for over two years compared to other treatments.

Conclusion

With the launch of Osvyrti and Jubereq, Accord Healthcare reinforces its commitment to providing high-quality, affordable treatment alternatives in critical areas of healthcare, particularly in bone health. As part of their strategic goal to launch 20 biosimilars by 2030, these products mark a significant advancement toward improving patient outcomes and access to necessary therapies. By focusing on the biosimilar segment of the pharmaceutical market, Accord is set to make a substantial difference in the lives of millions of individuals impacted by osteoporosis and other bone-related conditions.