Denosumab Medicine 03 June 2025 Extended indication Preventie van botcomplicaties (pathologische fractuur, bestraling van bot, ruggenmergcompressie of chirurgie van het bot) bij volwassenen met botmetastasen van solide tumoren. Behandeling van volwassenen en adolescenten met een volgroeid skelet met reusceltumor van het bot (‘giant cell tumour of bone’) die niet-reseceerbaar is of waarbij chirurgische resectie waarschijnlijk leidt tot ernstige morbiditeit. Therapeutic value Possible equal value Total cost Registration phase Registered Product Active substance Denosumab Domain Oncology Reason of inclusion Biosimilar BS Main indication Oncology other Extended indication Preventie van botcomplicaties (pathologische fractuur, bestraling van bot, ruggenmergcompressie of chirurgie van het bot) bij volwassenen met botmetastasen van solide tumoren. Behandeling van volwassenen en adolescenten met een volgroeid skelet met reusceltumor van het bot (‘giant cell tumour of bone’) die niet-reseceerbaar is of waarbij chirurgische resectie waarschijnlijk leidt tot ernstige morbiditeit. Current proprietary name Xgeva Already available biosimilars / generics Proprietary name Manufacturer Gedeon Portfolio holder Gedeon Mechanism of action Route of administration Subcutaneous Therapeutical formulation Injection / infusion solution Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date July 2024 Expected Registration June 2025 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks Positieve CHMP opinie in april 2025. Therapeutic value Current treatment options Xgeva Therapeutic value Possible equal value This assessment does not indicate any potential inclusion in the package. Substantiation Biosimilar Duration of treatment Frequency of administration 1 times every 4 weeks Dosage per administration 120mg References Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Expected cost per patient per year Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References Additional remarks Other information Additional remarks