Accord Healthcare Unveils Denosumab Biosimilars Osvyrti and Jubereq for Bone Health

Accord Healthcare Launches Denosumab Biosimilars

Accord Healthcare, a rapidly growing pharmaceutical company focused on generics and biosimilars, recently announced the launch of two new biosimilars targeting bone health: Osvyrti (denosumab), a biosimilar to Prolia® (Amgen), and Jubereq (denosumab), a biosimilar to Xgeva® (Amgen). This launch comes after the expiration of the reference drug's patent on November 27, 2025, marking an important milestone in the availability of alternative treatment options for patients.

Both biosimilars received approval from the European Medicines Agency (EMA) in September of this year, supported by clinical trials demonstrating their substantial similarity to Prolia® and Xgeva®. These developments allow Accord Healthcare to expand its portfolio of biosimilars aimed at addressing the crucial therapeutic area of bone health, emphasizing the company's commitment to increasing patient access to safe, high-quality, and affordable medications.

A Dual Approach to Bone Health

Osvyrti is designed for treating osteoporosis in postmenopausal women and men at high risk for fractures. Additionally, it is indicated for bone loss associated with hormonal ablation in men with prostate cancer and long-term systemic glucocorticoid therapy in adults at increased fracture risk. It comes in convenient pre-filled syringes of 60 mg.

On the other hand, Jubereq is intended for preventing skeletal-related events such as pathological fractures and spinal cord compression in adults with advanced malignancies affecting the bone. This medication is available in 120 mg vials and is also indicated for treating adults and adolescents with unresectable giant cell tumors of the bone.

Paul Tredwell, Global CEO of Accord Healthcare, commented on the importance of these biosimilars: “Both Osvyrti and Jubereq have been approved for a wide range of bone-related indications, including osteoporosis and bone loss due to certain cancer treatments. These biosimilars have the potential to provide a significant number of patients with cost-effective treatment alternatives, thus minimizing financial barriers to accessing proven therapies.” Tredwell added that Accord aims to have a total of 20 biosimilars on the market by 2030, underscoring its dedication to leading biosimilar adoption in the healthcare sector.

Addressing Osteoporosis Burden

Osteoporosis is a chronic condition defined by reduced bone mass and structural deterioration, increasing the risk of fractures. This condition affects over 200 million people globally, with approximately one in three women and one in five men over the age of 50 experiencing an osteoporotic fracture in their lifetime. As the global population ages, the prevalence and economic burden of osteoporosis are expected to grow, straining healthcare systems around the world.

Clinical trials for Osvyrti demonstrated comparable increases in lumbar spine bone mineral density (BMD) after 12 months of treatment. Both Osvyrti and Jubereq exhibited equivalent pharmacokinetic, pharmacodynamic, safety, and immunogenicity profiles, which further strengthens the evidence for their clinical interchangeability with their reference products. The trials also revealed a low incidence of anti-drug antibodies among patients treated with either biosimilar.

Jubereq showed demonstrated bioequivalence with its reference product, with no significant clinical differences in efficacy, safety, or pharmacokinetics. Notably, it has proven to be effective in preventing skeletal-related events for over two years, highlighting its potential impact on patients with advanced cancers.

Summary

The launch of Osvyrti and Jubereq signifies Accord Healthcare's commitment to providing healthcare professionals with effective tools to improve patient outcomes in bone health management. These biosimilars not only enhance treatment options for patients but also represent a strategic effort to make necessary therapies more accessible and affordable. Accord continues to focus on innovation and quality, striving to meet the needs of patients and healthcare systems worldwide.

For more information about these products, healthcare professionals can refer to the prescribing information provided by Accord Healthcare.