Jubbonti (denosumab-bddz) / Sandoz - LARVOL DELTA

NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Adult Cancer Pain, Version 3.2024. (NCCN)

NCCN guideline • Oncology • Pain

The Totality of Evidence for SDZ-deno: A Biosimilar to Reference Denosumab. (PubMed, Clin Ther) - "The ToE for SDZ-deno suggests it will be an effective biosimilar to REF-deno, and its lower unit price is anticipated to increase the number of appropriate patients who will benefit."

Journal • Review • Oncology • Orthopedics • Osteoporosis • Rheumatology

NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines), the NCCN Drugs & Biologics Compendium (NCCN Compendium), the NCCN Radiation Therapy Compendium, and the NCCN Imaging Appropriate Use Criteria (NCCN Imaging AUC) for Bone Cancer, Version 1.2025. (NCCN)

NCCN guideline • Chordoma • Ewing Sarcoma • Giant Cell Tumor of Bone • Osteosarcoma

Sandoz reports second-quarter sales and half-year 2024 results (GlobeNewswire) - "In recent months, we saw strong uptake of Hyrimoz in the US, received approval for Pyzchiva (ustekinumab) and Wyost/Jubbonti (denosumab) in the US and Europe and secured a settlement agreement in the US with launch dates in the first half of 2025....Total cash and cash equivalents decreased to USD 0.7 billion on June 30, 2024, compared to USD 1.1 billion on December 31, 2023. Net cash flows from operating activities were more than offset by our first dividend payment of USD 215 million and the Cimerli acquisition of USD 188 million."

Biosimilar launch • Commercial • Age-related Macular Degeneration • Crohn's disease • Immunology • Inflammatory Bowel Disease • Macular Degeneration • Ophthalmology • Osteoporosis • Psoriasis • Ulcerative Colitis • Wet Age-related Macular Degeneration

Drugs for postmenopausal osteoporosis. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Review • Osteoporosis • Rheumatology

Sandoz receives European Commission approval for Wyost and Jubbonti, the first and only biosimilars of denosumab in Europe (Sandoz Press Release) - "Sandoz...announced that the European Commission (EC) has granted marketing authorization for Wyost (denosumab) and Jubbonti (denosumab), the first and only biosimilar versions of reference medicines Xgeva and Prolia in Europe. Wyost is approved for the treatment of cancer-related bone disease. Jubbonti is approved to treat osteoporosis....We expect to launch from November 2025 onwards."

EMA approval • Launch Europe • Metabolic Disorders • Osteoporosis

Equivalence trial of proposed denosumab biosimilar GP2411 and reference denosumab in postmenopausal osteoporosis: the ROSALIA study. (PubMed, J Bone Miner Res) - "Treatment-emergent adverse events were comparable between groups (63.6% [GP2411/GP2411]; 76.0% [REF-DMAb/REF-DMAb]; 76.6% [REF-DMAb/GP2411]). In conclusion, ROSALIA showed similar efficacy, PK and PD, and comparable safety and immunogenicity of GP2411 to REF-DMAb in postmenopausal osteoporosis."

Journal • Musculoskeletal Diseases • Orthopedics • Osteoporosis • Rheumatology

Sandoz receives FDA approval for first and only denosumab biosimilars (GlobeNewswire) - "Sandoz...today announced that the US Food and Drug Administration (FDA) approved Wyost (denosumab-bbdz) and Jubbonti (denosumab-bbdz), the first and only FDA-approved denosumab biosimilars, to treat all indications of the reference medicines....Wyost is approved to prevent skeletal-related events (SREs) in patients with multiple myeloma and in patients with bone metastases from solid tumors, to treat adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity, and to treat hypercalcemia of malignancy refractory to bisphosphonate therapy."

BLA • Metabolic Disorders • Osteoporosis

Sandoz receives Health Canada approval for Jubbonti, first and only denosumab biosimilar for treatment of osteoporosis (GlobeNewswire) - "Sandoz Canada is pleased to announce that Health Canada has provided authorization to market Jubbonti (denosumab subcutaneous injection, reference medicine: Prolia)....Jubbonti should be available on the Canadian market in the coming months."

Canadian regulatory • Launch Canada • Metabolic Disorders • Osteoporosis

Pharmacokinetics and pharmacodynamics of the proposed biosimilar denosumab GP2411 and reference denosumab in healthy males. (PubMed, Expert Opin Biol Ther) - "GP2411 demonstrated similarity with EU-Xgeva® and US-Xgeva® in PK, PD, safety, and immunogenicity in this population. EudraCT 2019 -001,651-39."

Journal • PK/PD data

Denosumab Reduces Type II Diabetes Risk. The British Medical Journal has published a matched cohort analysis demonstrating that adults receiving denosumab had a lower risk of NIDDM compared with those taking oral bisphosphonates for osteoporosis. https://bit.ly/3v9cDBh

Pharmacokinetics and pharmacodynamics of proposed denosumab biosimilar and reference denosumab in healthy male subjects. (ASCO 2023) - "PK and PD similarity between GP2411, a proposed Sandoz denosumab biosimilar, and reference denosumab were demonstrated in healthy male subjects. >PE, point estimate."

Clinical • PK/PD data

Sandoz Marketing Authorization Applications for proposed biosimilar denosumab accepted by EMA (GlobeNewswire) - "Sandoz...today announced that the European Medicines Agency (EMA) has accepted the marketing authorization applications (MAA) for proposed biosimilar denosumab for regulatory review....The EMA applications are based on a comprehensive analytical and clinical data package, comprised of data from a Phase I PK/PD similarity study in healthy volunteers and the integrated Phase I/III ROSALIA study."

European regulatory • Metabolic Disorders • Osteoporosis

Sandoz Biologics License Application for proposed biosimilar denosumab accepted by US FDA (GlobeNewswire) - "Sandoz...announced that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for proposed biosimilar denosumab....The BLA includes a comprehensive analytical and clinical data package, including data from the Phase I/III ROSALIA study."

BLA • Giant Cell Tumor of Bone • Oncology • Osteoporosis • Solid Tumor

Study Investigating PK, PD, Efficacy, Safety, and Immunogenicity of Biosimilar Denosumab (GP2411) in Patients With Postmenopausal Osteoporosis (clinicaltrials.gov) - P3 | N=527 | Completed | Sponsor: Sandoz | Active, not recruiting ➔ Completed

Trial completion • Osteoporosis • Rheumatology

Study Investigating PK, PD, Efficacy, Safety, and Immunogenicity of Biosimilar Denosumab (GP2411) in Patients With Postmenopausal Osteoporosis (clinicaltrials.gov) - P3 | N=527 | Active, not recruiting | Sponsor: Sandoz | Trial primary completion date: Oct 2021 ➔ May 2022

Trial primary completion date • Osteoporosis • Rheumatology

Despite ’great strides’ in osteoporosis, questions remain (Healio) - '"We are making great strides in osteoporosis,' Nancy E. Lane, MD...said in her presentation. Lane covered topics ranging from what she called the 'crisis in treatment' of osteoporosis to specific issues surrounding bisphosphonates or denosumab and what is happening on the research front in glucocorticoids. But before digging into the pharmacotherapeutic options, Lane reminded CCR-East attendees that prevention is critical. “We should do preventive measures for everyone,” she said, citing exercise, calcium, screening and vitamin D intake as important tools for mitigating the disease."

Media quote

Study Investigating PK, PD, Efficacy, Safety, and Immunogenicity of Biosimilar Denosumab (GP2411) in Patients With Postmenopausal Osteoporosis (clinicaltrials.gov) - P3; N=492; Recruiting; Sponsor: Sandoz; Active, not recruiting ➔ Recruiting

Enrollment open • Osteoporosis • Rheumatology

Study Investigating PK, PD, Efficacy, Safety, and Immunogenicity of Biosimilar Denosumab (GP2411) in Patients With Postmenopausal Osteoporosis (clinicaltrials.gov) - P3; N=527; Active, not recruiting; Sponsor: Sandoz; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Osteoporosis • Rheumatology