First FDA-Approved Biosimilar for Gedeon Richter

Gedeon Richter Plc. and Hikma Pharmaceuticals Plc. along with its wholly owned subsidiary Hikma Pharmaceuticals USA Inc. (“Hikma”) announcee this Monday that the U.S. Food and Drug Administration (FDA) has granted approval for the Biologics License Applications (BLA) of their biosimilar denosumab products, EnobyTM (denosumab-qbde) and XtrenboTM (denosumabqbde), referencing Prolia® and Xgeva®, respectively.

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 EnobyTM, originally known as RGB-14-P and XtrenboTM, originally known as RGB-14-X, 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 EnobyTM and XtrenboTM have similar quality, efficacy, safety and immunogenicity as the reference denosumab products Prolia® and Xgeva®, respectively.

Hikma and Richter entered into a license and commercialization agreement for RGB-14 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 U.S.

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

According to Dr. Erik Bogsch, Head of Biotechnology Business Unit at Richter, ”the approvals of EnobyTM and XtrenboTM 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.”