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Ranibizumab

Byooviz

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 Byooviz
Manufacturer Samsung Bioepis
Mechanism of action Angiogenesis inhibitor
Budgetting framework Intermural (MSZ)
Additional remarks Dit betreft 1 van de vier biosimilars voor ranibizumab die is opgenomen in de Horizonscan Geneesmiddelen.

Registration

Registration route Centralised (EMA)
Submission date September 2020
Expected Registration August 2021
Orphan drug No
Registration phase Registered
Additional remarks Momenteel loopt er een fase 3 studie (NCT03150589). SPC Lucentis verloopt op 23/07/2022. Positieve Opinie augustus 2021.

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.