EC approves SandozSandoz’s biosimilars for bone-related ailments

23 May 2024
www.pharmaceutical-technology.com
Drug Approval
EC approves Sandoz’s biosimilars for bone-related ailments
Preview
Source: Pharmaceutical Technology
Sandoz plans to launch the biosimilar products for bone-related ailments from November 2025. Credit: Tong_stocker / Shutterstock.com.
The European Commission (EC) has granted marketing authorisation for SandozSandoz’s biosimilars Wyost (denosumab) and Jubbonti (denosumab) for bone-related ailments.
Wyost and Jubbonti are the first biosimilars of reference medicines Xgeva and Prolia to receive approval in Europe.
Wyost is indicated for the prevention of skeletal-related events in adults with advanced malignancies involving bone. It is also intended for the treatment of adult and skeletally mature adolescent patients with giant cell bone tumours.
Sandoz’s Jubbonti can be used for the treatment of osteoporosis in postmenopausal women and men at increased risk of fractures, among other bone loss conditions.
The company plans to launch these products from November 2025.
See Also:ASCO 2024: Verastem’s combo therapy for pancreatic cancer hits early trial success
EC approves Sandoz’s biosimilars for bone-related ailments
Preview
Source: Pharmaceutical Technology
FDA advisory committee reviews Novo Nordisk insulin icodec for T1D
EC approves Sandoz’s biosimilars for bone-related ailments
Preview
Source: Pharmaceutical Technology
Wyost and Jubbonti contain denosumab, a human monoclonal antibody that hinders the RANKL/RANK interaction. This mechanism is crucial as it prevents the formation and activity of osteoclasts, cells responsible for bone resorption, thus aiding in the maintenance of bone integrity.
The EC’s authorisation for Wyost and Jubbonti was based on comprehensive development programmes that demonstrated biosimilarity to their reference medicines.
The biosimilars have been developed to match the original products in terms of dosage form, route of administration, dosing regimen and presentation.
Sandoz chief scientific officer Claire D’Abreu-Hayling stated: “Primary and secondary bone loss, as well as cancer-related bone events, represent an immense disease burden for patients, the economy and society as a whole.
“The approval of the first European denosumab biosimilars is a crucial recognition of the need for increased access to these potentially life-changing medicines and demonstrates our continued commitment to delivering more sustainable treatment options for patients, in Europe and beyond.”
In March 2024, the US Food and Drug Administration approved SandozSandoz’s Wyost (denosumab-bbdz) and Jubbonti (denosumab-bbdz) as denosumab biosimilars.
For more details,please visit the original website
The content of the article does not represent any opinions of Synapse and its affiliated companies. If there is any copyright infringement or error, please contact us, and we will deal with it within 24 hours.
Organizations
Indications
Targets
Drugs
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.