Insulin aspart Medicine 10 December 2019 Extended indication The treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above. Therapeutic value Possible equal value Total cost Registration phase Registered and reimbursed Product Active substance Insulin aspart Domain Metabolism and Endocrinology Reason of inclusion Biosimilar BS Main indication Diabetes Extended indication The treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above. Current proprietary name NovoRapid (Novo Nordisk) Already available biosimilars / generics Proprietary name Insulin aspart Sanofi Manufacturer Sanofi Portfolio holder Mechanism of action Receptor agonist Route of administration Unknown Therapeutical formulation Unknown Budgetting framework Unknown Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date July 2019 Expected Registration June 2020 Orphan drug Unknown Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks SPC is inmiddels verlopen. Positieve CHMP-opinie in april 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