Natalizumab Medicine 07 December 2022 Extended indication actieve relapsing-remitting multiple sclerose (zie indicatie huidige spécialité). Therapeutic value Possible equal value Total cost Registration phase Registered and reimbursed Product Active substance Natalizumab Domain Neurological disorders Reason of inclusion Biosimilar BS Main indication Multiple sclerosis Extended indication actieve relapsing-remitting multiple sclerose (zie indicatie huidige spécialité). Current proprietary name Tysabri (Biogen) Already available biosimilars / generics Geen Proprietary name Manufacturer Polpharma Portfolio holder Mechanism of action Immunosuppression Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date July 2022 Expected Registration September 2023 Orphan drug Unknown Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie juli 2023. Laatste patent dat verloopt is als volgt genaamd "NATALIZUMAB ANTIBODY FORMULATIONS" en is geldig tot en met 12 juni 2028. 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