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FDA Approves Enoby

FDA Approves Enoby (denosumab-qbde), a Biosimilar to Prolia

September 2025

Budapest, Hungary and London, UK, 29 September 2025 – Gedeon Richter Plc. (“Richter”) and Hikma Pharmaceuticals Plc. along with its wholly owned subsidiary Hikma Pharmaceuticals USA Inc. (“Hikma”) announce today that the U.S. Food and Drug Administration (FDA) has granted approval for the Biologics License Application (BLA) of Enoby (denosumab-qbde) biosimilar denosumab product referencing Prolia.

The FDA also approved Xtrenbo (denosumab-qbde), a biosimilar denosumab product referencing Xgeva.

Denosumab is indicated for treating osteoporosis in postmenopausal women, preventing skeletal-related complications in cancer that has spread to the bone, and treating unresectable giant cell tumor of the bone.

The FDA approval of Enoby, originally known as RGB-14-P, was based on a comprehensive analytical, non-clinical, and clinical data package submitted by Hikma to the FDA. The content of the BLA demonstrated that Enoby has similar quality, efficacy, safety and immunogenicity as the reference denosumab product Prolia.

Hikma and Richter entered into a license and commercialization agreement for RGB-14 products in December 2021. Under the terms of the agreement, Richter is responsible for the development and manufacture of the products, and Hikma is responsible for the FDA registration and exclusive commercialization in the US.

“We are proud to be able to bring these biosimilar options to healthcare providers and patients, improving affordability and access to these important therapies,” said Dr. Bill Larkins, President of Hikma Injectables. “We are a top-three US provider of sterile injectable medicines to US hospitals and we will use our strong and well-established commercial capabilities to bring these products to patients.”

“The approvals of Enoby and Xtrenbo represent a significant milestone accomplishment for Richter, as our first FDA approved biosimilars. They are a testimony to Richter’s ambition in providing affordable biosimilar access in important therapies to patients across the globe and establishing Richter as a high quality biosimilar developer and manufacturer.” said Dr. Erik Bogsch, Head of Biotechnology Business Unit at Richter.

About Enoby

Enoby contains denosumab, a human monoclonal antibody (IgG2) that targets and binds with high affinity to RANKL, inhibiting its interaction with the RANK receptor on osteoclasts and their precursors. This mechanism prevents osteoclast formation, function, and survival, thereby reducing bone resorption in both cortical and trabecular bone. This product is administered subcutaneously, with dosing regimens and presentations identical to those of the reference medicine.

Source: Hikma Pharmaceuticals plc

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Enoby (denosumab-qbde) FDA Approval History

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