Jubereq (denosumab-desu) / Intas - LARVOL DELTA

Accord BioPharma, the U.S. specialty division of Intas Pharmaceuticals, is launching two denosumab biosimilars—Osvyrti and Jubereq. (Drug Store News) - "Osvyrti is available at a wholesaler acquisition cost of $1,800.41 per 60 mg/ml single-dose pre-filled syringe, and Jubereq at a WAC price of $3,311.75 per 120 mg/1.7 ml (70 mg/ml) single-dose vial, supplying providers with more cost-efficient acquisition options for denosumab therapy."

Biosimilar launch • Giant Cell Tumor of Bone • Osteoporosis

Comparison of pharmacokinetics, pharmacodynamics, safety, and immunogenicity of a candidate biosimilar INTP23.1 with EU and US‑approved denosumab reference products in healthy adult men. (PubMed, Naunyn Schmiedebergs Arch Pharmacol) - "INTP23.1 demonstrated comparable PK, PD, immunogenicity, and safety to US- and EU-licensed denosumab reference products in healthy male volunteers. These findings support further clinical development of INTP23.1 as a denosumab biosimilar for approved indications."

Clinical • Journal • PK/PD data • Osteoporosis • Rheumatology

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