Tocilizumab Medicine 13 December 2018 Extended indication Rheumatoid arthritis (RA), giant lymph node hyperplasia (Castlesman’s disease), polyarticular idioathic juvenile arthritis (PJIA) and systemic juvenile idiopathic arthritis (SJIA). Therapeutic value Possible equal value Total cost Registration phase No registration expected Product Active substance Tocilizumab Domain Chronic immune diseases Reason of inclusion Biosimilar BS Main indication Rheumatism Extended indication Rheumatoid arthritis (RA), giant lymph node hyperplasia (Castlesman’s disease), polyarticular idioathic juvenile arthritis (PJIA) and systemic juvenile idiopathic arthritis (SJIA). Current proprietary name RoActemra (Roche) Already available biosimilars / generics Proprietary name Onteeo Manufacturer Fresenius Kabi Portfolio holder Mechanism of action Interleukin inhibitor Route of administration Unknown Therapeutical formulation Unknown Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Fabrikant: Fresenius Kabi Deutschland GmbH Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date August 2022 Expected Registration Orphan drug No Registration phase No registration expected Reimbursement Medicine sluice Additional remarks SPC RoActemra verloopt op 6 juni 2020. Er zijn 2 indieningen voor Tocilizumab biosimilars geweest bij de EMA 1 in augustus en 1 in september. CHMP opinie 30 maart 2023: Teruggetrokken Therapeutic value Current treatment options Therapeutic value Possible equal value This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration 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 Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks