• UPDATE: Hikma Pharmaceuticals Launches Denosumab Biosimilars Enoby™ and Xtrenbo™ in US Market
LONDON, United Kingdom – Hikma Pharmaceuticals PLC announced on January 19 the United States launch of Enoby™ and Xtrenbo™, two biosimilar products for treating osteoporosis and preventing bone complications from cancer.
What is new?
Hikma Pharmaceuticals, through its wholly owned subsidiary Hikma Pharmaceuticals USA Inc., has launched Enoby™ (denosumab-qbde) and Xtrenbo™ (denosumab-qbde). These products are biosimilars referencing Prolia® and Xgeva®, respectively. Denosumab is indicated for treating osteoporosis in postmenopausal women, preventing skeletal-related events in patients with bone metastases from solid tumors, and treating giant cell tumor of the bone.
Partnership and Production
The launch is part of a license and commercialization agreement established in 2021 between Hikma and Gedeon Richter Plc. Under the terms of the agreement, Richter is responsible for the manufacturing of the products, which were originally known as RGB-14. Hikma holds exclusive rights for commercialization within the US market.
Product Details
Both Enoby™ and Xtrenbo™ contain denosumab, a human monoclonal antibody that inhibits the formation and function of osteoclasts, cells responsible for bone resorption. This action helps reduce bone loss. The products are administered via subcutaneous injection, with dosing and presentation identical to their reference medicines. Craig Boyd, VP of Specialty Products, Injectables, stated, “We are excited to have launched our second biosimilar in the US… We look forward to leveraging our strong commercial capabilities to increase affordable access to these important products.” The launch expands Hikma’s portfolio to over 180 injectable products.
Key Safety Information
The products carry a warning for severe hypocalcemia, particularly in patients with advanced chronic kidney disease, including those on dialysis. Cases have been reported as life-threatening and fatal. Healthcare providers are advised to evaluate for chronic kidney disease-mineral bone disorder (CKD-MBD) before initiating treatment in this patient group. Enoby™ and Xtrenbo™ are contraindicated in patients with pre-existing hypocalcemia, pregnant women, and individuals with a known hypersensitivity to denosumab products.
About this company
Hikma Pharmaceuticals PLC is a global pharmaceutical company headquartered in the United Kingdom. For over 45 years, the company has focused on creating and providing access to high-quality branded and non-branded generic medicines. With a workforce of 9,100 colleagues, Hikma maintains a local presence in North America, the Middle East and North Africa (MENA), and Europe. The company also acts as a licensing partner and invests in innovative health technologies through its venture capital arm.
Read more
https://www.hikma.com/news/hikma-announces-launch-of-enoby-denosumab-qbde-and-xtrenbo-denosumab-qbde-referencing-prolia-and-xgeva-respectively/
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