#USA #London #Accord Healthcare #OSVYRTI #Jubereq

Accord Healthcare Introduces Osvyrti and Jubereq

Accord Healthcare has announced the launch of two promising biosimilars, Osvyrti (denosumab) and Jubereq (denosumab), designed to provide affordable treatment options for patients dealing with bone health issues. This strategic move follows the patent expiration of the reference drugs, Prolia® and Xgeva®, making these healthcare solutions available for practitioners and patients alike.

Understanding Osvyrti and Jubereq

The European Medicines Agency (EMA) approved both biosimilars in September, indicating their close resemblance to their respective reference products. Osvyrti, available in a 60 mg pre-filled syringe, is particularly aimed at treating osteoporosis in postmenopausal women and in men at increased risk of fractures. Additionally, it addresses bone loss resulting from hormone ablation in prostate cancer patients and extended glucocorticoid therapy.

Meanwhile, Jubereq, provided in a 120 mg vial, serves to mitigate skeletal-related events for adults with advanced malignancies involving bones. Furthermore, it plays a crucial role in treating unresectable giant cell tumors in adults and skeletally mature adolescents.

An Urgent Need—Osteoporosis

Osteoporosis is a global health crisis that impacts over 200 million people, leading to significant economic and physical burdens. About one in three women and one in five men over the age of 50 are expected to face osteoporotic fractures, highlighting a significant healthcare concern as populations globally continue to age. Accord Healthcare aims to alleviate this burden through their newly launched biosimilars, enhancing both treatment access and affordability.

Clinical Proof and Patient Benefits

The approval of Osvyrti and Jubereq is backed by rigorous clinical trials. The Phase III study demonstrated that Osvyrti matched the efficacy and safety profile of Prolia, with no meaningful differences in pharmacokinetics, pharmacodynamics, or immunogenicity. In fact, results showed that there were no adverse immunological responses, with an incidence of anti-drug antibodies under 1.6% across both treatment groups.

Jubereq has also showcased its bioequivalence to Xgeva, solidifying its place as a compelling alternative. Patients, especially those suffering from metastatic prostate cancer, reported marked improvements in quality of life post-treatment, further validating the clinical merits of these biosimilars.

Accord Healthcare’s Vision for the Future

Paul Tredwell, Global CEO of Accord Healthcare, emphasized the importance of healthcare access: “Both Osvyrti and Jubereq have been approved for wide-ranging bone-related conditions, which could significantly alleviate the financial burden of proven therapies for patients.” The company is committed to promoting biosimilar use, aiming for at least 20 biosimilars on the market by 2030.

Accord positions itself as a leading player in the biosimilar field, dedicated to improving patient outcomes without compromising quality. As the need for effective and accessible treatment options grows, Osvyrti and Jubereq could be game-changers for those affected by osteoporosis and bone-related cancers.

In conclusion, the launch of Osvyrti and Jubereq not only marks a significant step in the advancement of bone health solutions but also represents Accord Healthcare's overarching mission to enhance healthcare accessibility and sustainability.