Aflibercept Medicine 13 December 2018 Extended indication Diabetic macular edema Therapeutic value Possible equal value Total cost Registration phase Clinical trials Product Active substance Aflibercept Domain Neurological disorders Reason of inclusion Biosimilar BS Main indication Eye disorders Extended indication Diabetic macular edema Current proprietary name Eylea (Bayer) Already available biosimilars / generics Proprietary name M710 Manufacturer Momenta/Mylan Portfolio holder Mechanism of action Angiogenesis inhibitor 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 No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Momenteel loopt er een fase III studie (EudraCT Number: 2017-004358-40). SPC Eylea verloopt op 22-05-2025. 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