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Golimumab

Medicine

Extended indication Simponi is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients 2 years of age and older with a body
Therapeutic value No estimate possible yet
Registration phase Registered

Product

Active substance Golimumab
Domain Chronic immune diseases
Reason of inclusion Indication extension IND
Main indication Bowel diseases
Extended indication Simponi is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients 2 years of age and older with a body weight of at least 15 kg, who have had an inadequate response to conventional therapy, including corticosteroids and 6‑mercaptopurine (6‑MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Proprietary name Simponi
Manufacturer Janssen
Portfolio holder Janssen
Mechanism of action Other, see general comments
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)
Additional remarks CD20-bindend antilichaam

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date January 2025
Expected Registration January 2026
Orphan drug No
Registration phase Registered
Reimbursement Reimbursed from the basic package
Medicine sluice Rejected
Additional remarks Positieve CHMP-opinie in december 2025.

Therapeutic value

Current treatment options 5‑ASA‑preparaten, corticosteroïden, immunomodulatoren, TNFa-remmers.
Therapeutic value No estimate possible yet

This assessment does not indicate any potential inclusion in the package.
Substantiation Jonge kinderen met colitis ulcerosa worden nu behandeld met TNFa-remmers, veelal met infliximab of adalimumab. Golimumab zou die plaats ook kunnen opvullen. Echter is infliximab vele malen goedkoper, omdat hier al reeds biosimilar-varianten van op de markt zijn.
References NCT03596645 (PURSUIT 2); Expertopinie

Expected patient volume per year

Patient volume

Market share is generally not included unless otherwise stated.
References UMCG (1); Declaratiedata (2); Expertopinie (3)
Additional remarks In Nederland krijgen elk jaar ongeveer 150 kinderen onder de 18 jaar de diagnose colitis ulcerosa (1). Er zijn ongeveer 200 volwassen gebruikers van Simponi voor colitis ulcerosa (2). Mogelijk komen er 25 patiënten in aanmerking voor deze indicatieuitbreiding.

Expected cost per patient per year

Potential total cost per year

Off label use

Indication extension

Other information