Hikma Launches Enoby And Xtrenbo Denosumab Biosimilars In The U.S., Expands Biosimilars Portfolio

Hikma Pharmaceuticals PLC, together with its wholly owned subsidiary Hikma Pharmaceuticals USA Inc., has announced the U.S. launch of Enoby™ and Xtrenbo™, biosimilar versions of denosumab-qbde referencing Amgen’s Prolia® and Xgeva®, respectively. The launch marks an important expansion of Hikma’s biosimilars portfolio in the U.S. market, aimed at improving access to high-quality biologic therapies.

The products were developed under a license and commercialization agreement signed in 2021 between Hikma and Gedeon Richter Plc. Under the terms of the collaboration, Richter is responsible for manufacturing Enoby™ and Xtrenbo™, while Hikma holds exclusive rights for commercialization in the United States.

“We are excited to have launched our second biosimilar in the US and are proud to be able to bring these biosimilar options to healthcare providers and patients” said Craig Boyd, VP Specialty Products, Injectables. “We are a top-three US provider of sterile injectable medicines to US hospitals and this launch further broadens our portfolio of over 180 injectable products. We look forward to leveraging our strong commercial capabilities to increase affordable access to these important products.” 

Denosumab is widely used in the management of bone-related conditions, including osteoporosis in postmenopausal women, prevention of skeletal-related events in patients with cancers that have metastasized to bone, and treatment of unresectable giant cell tumor of the bone. By introducing biosimilar options, Hikma aims to support broader patient access to these essential therapies.

Both Enoby™ and Xtrenbo™ contain denosumab, a human monoclonal IgG2 antibody that binds with high affinity to RANKL, blocking its interaction with the RANK receptor on osteoclasts and their precursors. This action inhibits osteoclast formation, function, and survival, leading to reduced bone resorption in cortical and trabecular bone. The biosimilars are administered subcutaneously and follow the same dosing schedules and presentations as their respective reference products.