Enoby and Xtrenbo are the latest denosumab biosimilars to receive FDA approval, referencing Prolia and Xgeva, respectively. The approval, announced October 14, is the seventh denosumab biosimilar.
Both are designated denosumab-qbde. Enoby is approved to treat the principal osteoporosis-related indications of Prolia, and Xtrenbo’s approval matches the oncology-related skeletal indications of Xgeva.
Gedeon Richter’s partner Hikma USA will commercialize these biosimilars in the US. ”The approvals of Enoby and Xtrenbo represent a significant milestone accomplishment for Richter, as our first FDA approved biosimilars,” stated Dr. Erik Bogsch, Head of the Biotechnology Business Unit at Richter. “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.”
Hikma is already involved in the US biosimilar market, as the commercialization partner of Bio-Thera for the ustekinumab biosimilar Starjemza. This latest news represents the first US biosimilar approval for the manufacturer Gedeon Richter.
The company has a strong presence in the EU and in women’s healthcare. The company’s website lists a tocilizumab biosimilar in clinical development, and two nondisclosed biosimilars in the autoimmune space in early characterization stages. Gedeon Richter also has a 10% equity stake in another biosimilar player—Formycon.
(Editor’s Note: This post was revised to reflect an initial posting error: Hikma is not owned by Gedeon RIchter.)
