Trastuzumab Medicine 04 June 2026 Extended indication Extension application to introduce a new pharmaceutical form (solution for injection), a new strength (600 mg) and a new route of administration (subcutaneous use). Therapeutic value Total cost Registration phase Registration application pending Product Active substance Trastuzumab Domain Oncology Reason of inclusion Indication extension IND Main indication Oncology other Extended indication Extension application to introduce a new pharmaceutical form (solution for injection), a new strength (600 mg) and a new route of administration (subcutaneous use). Current proprietary name Already available biosimilars / generics Proprietary name Zercepac Manufacturer Intas Portfolio holder Intas Mechanism of action Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Biosimilar Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity New therapeutical formulation ATMP No Submission date April 2026 Expected Registration March 2027 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value Substantiation Duration of treatment Frequency of administration Dosage per administration 600 mg 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 € 20,000.00 - 40,000.00 This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year. References medicijnkosten.nl Additional remarks Herceptin € 1.319,22 (inclusief BTW) per injectieflacon van 120 mg/ml flacon van 5 ml. 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