Jubereq (denosumab-desu) / Intas - LARVOL DELTA

Accord BioPharma, Inc. Announces FDA Approval of Denosumab Biosimilars OSVYRTI (denosumab-desu) and JUBEREQ (denosumab-desu) (PRNewswire) - "The approval of OSVYRTI and JUBEREQ is based on results from two trials: a Phase I trial and a Phase III trial that met their primary endpoints. The Phase I trial was a randomized, double-blind, three-arm pharmacokinetic (PK) study comparing JUBEREQ to Xgeva in healthy adult males."

FDA approval • Osteoporosis

Diagnosis, evaluation and management of osteoporosis in chronic kidney disease: navigating treatment approaches - Indian consensus statement. (PubMed, Front Nephrol) - "Tailored treatment strategies were recommended, with a judicious use of bisphosphonates and denosumab, depending on the patient's estimated glomerular filtration rate (eGFR) and bone turnover state. The recommendations emphasize individualized treatment approaches, the importance of early screening, and the integration of multidisciplinary care. These findings aim to fill existing knowledge gaps and improve clinical outcomes for CKD patients with osteoporosis."

Journal • Chronic Kidney Disease • Musculoskeletal Diseases • Nephrology • Orthopedics • Osteoporosis • Renal Disease • Rheumatology

Accord Healthcare Receives Positive CHMP Opinion for Denosumab, Osvyrti, and Jubereq (PRNewswire) - "Accord Healthcare Limited (Accord) is pleased to announce that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for Denosumab, including its branded formulations Osvyrti and Jubereq, across its autoimmune and oncology therapy areas. Osvyrti – Bone / Osteoporosis (60mg Pre-Filled Syringe); Jubereq – Oncology (120mg Vial)"

CHMP • Giant Cell Tumor of Bone • Osteoporosis