Omalizumab Medicine 13 December 2018 Extended indication Aanvullende behandeling om de astmacontrole te verbeteren bij patiënten met ernstig persistent allergisch astma. Therapeutic value Possible equal value Total cost Registration phase Clinical trials Product Active substance Omalizumab Domain Lung diseases Reason of inclusion Biosimilar BS Main indication Asthma Extended indication Aanvullende behandeling om de astmacontrole te verbeteren bij patiënten met ernstig persistent allergisch astma. Current proprietary name Xolair (Novartis) Already available biosimilars / generics Proprietary name STI-004 Manufacturer Sorrento Therapeutics Portfolio holder Mechanism of action Interleukin 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 Fase 2 en Fase 3 studie afgerond in mei 2016. SPC Xolair is verlopen. 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