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Golimumab

Extended indication Golimumab-lvtc in combination with methotrexate for treatment of moderate to severe active rheumatoi
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Golimumab
Domain Chronic immune diseases
Reason of inclusion Biosimilar
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
Mechanism of action TNF-alpha inhibitor
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Extramural (GVS)
Additional remarks Staat ook bekend als AVT05. Fabrikant: Alvotech

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date November 2024
Expected Registration December 2025
Orphan drug No
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.