Teduglutide Medicine 03 December 2024 Extended indication Treatment of Short Bowel Syndrome. Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Teduglutide Domain Chronic immune diseases Reason of inclusion Biosimilar BS Main indication Bowel diseases Extended indication Treatment of Short Bowel Syndrome. Current proprietary name Revestive Already available biosimilars / generics Proprietary name Manufacturer Takeda Portfolio holder Takeda Mechanism of action Glucagon analogue Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date November 2024 Expected Registration December 2025 Orphan drug Yes Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No estimate possible yet 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 Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks