Ranibizumab Medicine 13 December 2018 Extended indication Wet age-related macular degeneration (AMD). Therapeutic value Possible equal value Total cost Registration phase Registration application pending Product Active substance Ranibizumab Domain Neurological disorders Reason of inclusion Biosimilar BS Main indication Eye disorders Extended indication Wet age-related macular degeneration (AMD). Current proprietary name Lucentis (Novartis) Already available biosimilars / generics Proprietary name FYB201 Manufacturer Formycon AG Portfolio holder Mechanism of action Angiogenesis inhibitor Route of administration Unknown Therapeutical formulation Unknown Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Dit betreft 1 van de vier biosimilars voor ranibizumab die is opgenomen in de Horizonscan Geneesmiddelen. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date July 2021 Expected Registration July 2022 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Fase 3 studie afgerond in juli 2018 (NCT02611778). SPC Lucentis verloopt op 23/07/2022. 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