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Ustekinumab

Extended indication Moderately to severely active Ulcerative Colitis
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Ustekinumab
Domain Chronic immune diseases
Reason of inclusion Generic
Main indication Bowel diseases
Extended indication Moderately to severely active Ulcerative Colitis
Current proprietary name Stelara
Manufacturer Janssen
Mechanism of action Interleukin inhibitor
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)
Additional remarks IL12/23 remmer. 130 mg IV als inductie, daarna 90 mg SC als onderhoud elke 12 weken of elke 8 weken voor de patiënten die dat nodig hebben.

Registration

Registration route Centralised (EMA)
Submission date December 2022
Expected Registration January 2024
Registration phase Registration application pending

Therapeutic value

Therapeutic value No estimate possible yet

Expected patient volume per year

Patiëntvolume is niet van toepassing bij generieke geneesmiddelen of biosimilars.

Expected cost per patient per year

Horizonscan vermeldt geen prijsinformatie van generieke geneesmiddelen of biosimilars om het eventueel beïnvloeden van de markt te voorkomen.

Potential total cost per year

Horizonscan vermeldt geen prijsinformatie van generieke geneesmiddelen of biosimilars om het eventueel beïnvloeden van de markt te voorkomen.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.