Gedeon Richter Plc. and Hikma Pharmaceuticals Plc., along with wholly owned subsidiary Hikma Pharmaceuticals USA Inc., announced that the U.S. Food and Drug Administration (FDA) has approved their biosimilar denosumab products, Enoby and Xtrenbo.
Denosumab is used for treating osteoporosis (a skeletal disorder) in postmenopausal women, preventing bone complications in cancer patients, and treating unresectable giant cell tumor of the bone.
The FDA approval was based on detailed data submitted by Hikma, showing that Enoby and Xtrenbo match the original medications Prolia and Xgeva in quality, safety, efficacy, and immunogenicity.
Under a partnership formed in 2021, Richter developed and manufactured the biosimilars, while Hikma handled FDA registration and will exclusively market them in the United States.
Dr. Bill Larkins, President of Hikma Injectables, said: “We are proud to bring these biosimilar options to healthcare providers and patients, improving affordability and access to these important therapies.”
Dr. Erik Bogsch, Head of Biotechnology at Richter, noted that
these approvals mark an important milestone accomplishment for Richter as their first FDA-approved biosimilars.
Both Enoby and Xtrenbo contain denosumab, a human monoclonal antibody that binds to RANKL (a type of protein, known for affecting the immune system and controlling bone regeneration), blocking its interaction with the RANK receptor on bone-resorbing cells. This mechanism helps reduce bone loss. They are administered subcutaneously, with the same dosing and presentation as the reference medicines.
Richter shares took off following the U.S. announcement, with the share price rising 0.56% to HUF 9,825 (EUR 25.16) in the opening hour on September 29.
Fact
Gedeon Richter Plc. headquartered in Budapest, Hungary, is a major pharmaceutical company in Central and Eastern Europe, with an expanding direct presence in Western Europe, China, Latin America, and Australia. The product portfolio of Richter covers many important therapeutic areas, including Women’s Healthcare, Central Nervous System (CNS), and Cardiovascular areas. Having the largest R&D unit in Central and Eastern Europe, Richter’s original research activity focuses on CNS disorders.
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Via bet.hu, Featured image: Hungary Today
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