Golimumab Medicine 03 December 2024 Extended indication Golimumab-lvtc in combination with methotrexate for treatment of moderate to severe active rheumatoid arthritis in adults and elderly. Therapeutic value No estimate possible yet Total cost Registration phase Registered Product Active substance Golimumab Domain Chronic immune diseases Reason of inclusion Biosimilar BS Main indication Rheumatism Extended indication Golimumab-lvtc in combination with methotrexate for treatment of moderate to severe active rheumatoid arthritis in adults and elderly. Current proprietary name Simponi Already available biosimilars / generics Geen Proprietary name Manufacturer Alvotech Portfolio holder Mechanism of action Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date November 2024 Expected Registration November 2025 Orphan drug No Registration phase Registered Reimbursement Reimbursed from the basic package 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 NCT05842213 (ALVOFLEX) 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