Eculizumab Medicine 07 June 2022 Extended indication Paroxysmal nocturnal haemoglobinuria Therapeutic value Possible equal value Total cost Registration phase Registered and reimbursed Product Active substance Eculizumab Domain Cardiovascular diseases Reason of inclusion Biosimilar BS Main indication Other non-oncological hematological medications Extended indication Paroxysmal nocturnal haemoglobinuria Current proprietary name Soliris (Alexion) Already available biosimilars / generics Proprietary name Bekemv Manufacturer Amgen Portfolio holder Mechanism of action Immunostimulation Route of administration Unknown Therapeutical formulation Unknown Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date March 2022 Expected Registration April 2023 Orphan drug Yes Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks Biosimilar opgenomen in de "medicine under evaluation by the CHMP" van de EMA in maart 2022. SPC Soliris is verlopen op 30 april 2020. Positieve CHMP-opinie in februari 2023. Voor alle indicaties van Soliris geldt een financieel arrangement dat afloopt per eind 2025. Per juli is er nog een 2e biosimilar ingediend bij de EMA. 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