Tofacitinib Medicine 04 June 2026 Extended indication Tofacitinib monotherapy for treatment of Ankylosing spondylitis, Psoriatic arthritis, Rheumatoid arthritis, Ulcerative colitis, Juvenile idiopathic arthritis in children from 2 years of age and adults. Therapeutic value Possible equal value Total cost Registration phase Registration application pending Product Active substance Tofacitinib Domain Chronic immune diseases Reason of inclusion Biosimilar BS Main indication Rheumatism Extended indication Tofacitinib monotherapy for treatment of Ankylosing spondylitis, Psoriatic arthritis, Rheumatoid arthritis, Ulcerative colitis, Juvenile idiopathic arthritis in children from 2 years of age and adults. Current proprietary name Xeljanz (Pfizer) Already available biosimilars / generics Proprietary name Manufacturer Portfolio holder Mechanism of action JAK tyrosine kinase inhibitor Route of administration Therapeutical formulation Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Biosimilar ATMP No Submission date December 2025 Expected Registration January 2027 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value Possible equal value This assessment does not indicate any potential inclusion in the package. Substantiation biosimilar Duration of treatment Frequency of administration 2 times a day Dosage per administration 5mg of dosering afhankelijk van lichaamsgewicht tot 40kg. 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