Enoby (denosumab biosimilar) / Gedeon Richter, Hikma - LARVOL DELTA

A multicentre, randomised, double blind, phase I study comparing the pharmacokinetics and pharmacodynamics of proposed biosimilar RGB-14-X and reference denosumab in healthy adult males (ESMO 2025) - "Conclusions RGB-14-X and RD demonstrated equivalent PK and PD outcomes. Both were well tolerated, with similar immunogenicity and safety profiles."

Clinical • P1 data • PK/PD data • Oncology • Solid Tumor

A field test of whether herbivores mitigate the effects of plant invasions on soil biodiversity. (PubMed, J Anim Ecol) - "Research Highlight: Marco Fioratti Junod, Irene Cordero, Nadia Chinn, Jennifer Firn, Julia Holmes, Marcus Klein, Gabrielle Lebbink, Uffe N. Nielsen, Martin Schütz, Stephan Zimmermann, Anita C. Risch...The paper also highlights the difficulty of predicting the response of soil biodiversity to change because of unclear interdependencies among organisms. General techniques such as food web models, isotopic tracers and more detailed study of the lives of soil organisms will help us bridge this knowledge gap."

Journal

A randomised Phase 3 study comparing the efficacy and safety of proposed denosumab biosimilar RGB-14-P and reference denosumab in women with postmenopausal osteoporosis. (PubMed, Osteoporos Int) - P3 | "In women with postmenopausal osteoporosis, RGB-14-P demonstrated equivalent efficacy and pharmacodynamics, and similar immunogenicity and safety to denosumab."

Journal • P3 data • Musculoskeletal Diseases • Orthopedics • Osteoporosis • Rheumatology

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. (HungaryToday) - "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."

FDA approval • Giant Cell Tumor of Bone

Comprehensive Physico-chemical and Functional Similarity Assessment Study of RGB-14-P and RGB-14-X Drug Products as Proposed Biosimilars to Denosumab Reference Products. (PubMed, BioDrugs) - "The extensive analytical and functional similarity assessment study provides robust evidence that the structure and function of RGB-14-P and RGB-14-X are highly similar to those of EU/US Prolia® and Xgeva®."

Journal

Comparative Efficacy and Safety Study of RGB-14-P and Prolia® in Women With Postmenopausal Osteoporosis (clinicaltrials.gov) - P3 | N=473 | Completed | Sponsor: Gedeon Richter Plc. | Active, not recruiting ➔ Completed

Trial completion • Osteoporosis • Rheumatology

Comparative Efficacy and Safety Study of RGB-14-P and Prolia® in Women With Postmenopausal Osteoporosis (clinicaltrials.gov) - P3 | N=473 | Active, not recruiting | Sponsor: Gedeon Richter Plc. | Recruiting ➔ Active, not recruiting | Trial primary completion date: Jun 2023 ➔ Nov 2023

Enrollment closed • Trial primary completion date • Osteoporosis • Rheumatology