Accord Healthcare's Denosumab Approval: A Shift in Biosimilars
Accord Healthcare's Milestone in Biosimilars
Accord Healthcare Limited is celebrating a significant achievement after the Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for Denosumab, which will be marketed under the brand names Osvyrti and Jubereq. This milestone marks Accord's sixth biosimilar approval in Europe, signifying its ongoing commitment to providing patients with vital medicines.
Denosumab Overview
Denosumab is an invaluable treatment designed to combat osteoporosis and various oncology-related conditions. With Osvyrti focusing on bone health and Jubereq catering to cancer treatment, these products aim to reduce the risks associated with fractures and skeletal-related events. Accord plans to launch Denosumab following the patent expiry of the original brand, Prolia, and Xgeva, scheduled in November 2025.
Indications for Osvyrti
Osvyrti, available in a 60mg pre-filled syringe, is primarily indicated for osteoporosis treatment in postmenopausal women and men who are at an increased risk of fractures. Clinical trials have shown that Denosumab significantly lowers the chances of vertebral, non-vertebral, and hip fractures, making it a crucial option for those affected by this frail condition. Additionally, it is effective for men undergoing hormone ablation therapy due to prostate cancer, helping to mitigate the risk of fractures caused by bone loss. The indication also extends to adults experiencing bone loss due to long-term systemic glucocorticoid therapy.
Jubereq's Role in Oncology
Jubereq, administered in a 120mg vial, is formulated to prevent skeletal-related events such as pathological fractures or spinal cord compression in adults with advanced malignancies involving bones. It is also indicated for treating adults and skeletally mature adolescents with unresectable giant cell tumors of bone, or tumors where surgery could lead to severe complications. This expansion into oncology strengthens Accord's already impressive portfolio, which includes over 54 oncology-related treatments.
Expert Insights from Accord's Leadership
Joe Dunford, Accord's Vice President of Specialty Brands, emphasized the company's dedication to improving patient outcomes. He stated, "At Accord, we are dedicated to transforming patients' lives, and the recent CHMP approval of these vital medicines is a significant milestone. Osvyrti enhances our bone health portfolio, joining Sondelbay, our previously launched teriparatide biosimilar. Additionally, Jubereq expands our oncology product portfolio and underscores our commitment to advancing our specialty business."
Growth and Innovation in Oncology
As a prominent leader in oncology, Accord Healthcare offers various treatments, including small molecule generics and new chemical entities. This extensive range positions them as one of the largest providers of chemotherapy products across Europe. Accord's belief in innovation drives them to continually seek improvements in product accessibility and efficacy, ensuring that patients worldwide have the treatments they need.
About Accord Healthcare
Headquartered in the United Kingdom, Accord Healthcare has rapidly emerged as a leading pharmaceutical company in Europe. Its expansive market reach guarantees that over 95% of European patients gain access to crucial medications. With a robust pipeline that includes more than 20 additional treatments being developed for launch in the coming years, Accord remains focused on its mission to revolutionize health care and enhance patient well-being.
Frequently Asked Questions
What are the new products launched by Accord Healthcare?
Accord Healthcare has launched Denosumab, marketed as Osvyrti and Jubereq, enhancing their biosimilar product portfolio.
What conditions do Osvyrti and Jubereq treat?
Osvyrti is indicated for osteoporosis, while Jubereq is used for preventing skeletal-related events in cancer patients.
When can we expect Denosumab to become available?
Denosumab is expected to be available following the patent expiry of Prolia and Xgeva in November 2025.
How does Accord Healthcare support patient access to medications?
Accord Healthcare ensures over 95% of European patients have access to essential medicines through its wide market presence.
What is the significance of the CHMP's positive opinion?
The CHMP's positive opinion is a critical step towards obtaining market authorization for Denosumab, allowing Accord to launch the product successfully.
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