On September 29, 2025, Gedeon Richter Plc. ("Richter") and Hikma Pharmaceuticals Plc. along with its wholly owned subsidiary Hikma Pharmaceuticals USA Inc. ("Hikma") announced that the FDA approved their biosimilar denosumab products Enoby and Xtrenbo (denosumab-qbde), referencing Prolia and Xgeva respectively. This marks the seventh biosimilar denosumab approval.
Hikma and Richter previously entered into a license and commercialization agreement for the biosimilar in December 2021 giving Richter responsibility for the development and manufacture of the products and Hikma responsibility for FDA registration and exclusive commercialization in the US.
In commenting on the announcement, Dr. Bill Larkins, President of Hikma Injectables, stated that as "a top-three US provider of sterile injectable medicines to US hospitals [Hikma] will use [its] strong and well-established commercial capabilities to bring these products to patients." Meanwhile, Dr. Erik Bogsch, head of the Biotechnology Business Unit at Richter commented, "The approvals of Enoby and Xtrenbo represent a significant milestone accomplishment for Richter, as our first FDA approved biosimilars."
As we previously reported, Richter and Hikma's denosumab biosimilar is subject to BPCIA litigation brought by Amgen in June 2025. Stay tuned to Big Molecule Watch for further updates on this litigation.
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