Eculizumab Medicine 13 December 2018 Extended indication Paroxysmal nocturnal haemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS) Therapeutic value Possible equal value Total cost Registration phase Clinical trials Product Active substance Eculizumab Domain Cardiovascular diseases Reason of inclusion Biosimilar BS Main indication Other non-oncological hematological medications Extended indication Paroxysmal nocturnal haemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS) Current proprietary name Soliris (Alexion) Already available biosimilars / generics Proprietary name BOW080 Manufacturer Portfolio holder Mechanism of action Unknown Route of administration Unknown Therapeutical formulation Unknown Budgetting framework Unknown Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date Expected Registration Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Epirus was oorspronkelijk van plan een aanvraag in te dienen in 2020. In juli 2016 ging Epirus failliet en is BOW080 verkocht aan een niet-openbaar gemaakte koper. SPC Soliris verloopt op 30-04-2020. 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