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Ranibizumab

Ximluci

Extended indication Wet age-related macular degeneration (AMD)
Therapeutic value Possible equal value
Registration phase Registered

Product

Active substance Ranibizumab
Domain Neurological disorders
Reason of inclusion Biosimilar
Main indication Eye disorders
Extended indication Wet age-related macular degeneration (AMD)
Current proprietary name Lucentis (Novartis)
Proprietary name Ximluci
Mechanism of action Angiogenesis inhibitor
Budgetting framework Intermural (MSZ)
Additional remarks Fabrikant: STADA Arzneimittel AG

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date 2021
Expected Registration November 2022
Registration phase Registered
Additional remarks SPC Lucentis verloopt op 23 juli 2022. September 2022 positieve opinie.

Therapeutic value

Therapeutic value Possible equal value

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.