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

Product

Active substance Ranibizumab
Domain Neurological disorders
Reason of inclusion Biosimilar BS
Main indication Eye disorders
Extended indication Wet age-related macular degeneration (AMD).
Current proprietary name Lucentis (Novartis)
Proprietary name Xlucane
Manufacturer Xbrane Biopharma
Mechanism of action Angiogenesis inhibitor
Route of administration Unknown
Therapeutical formulation Unknown
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)
Type of trajectory Unknown
Particularity Unknown
ATMP Unknown
Orphan drug No
Registration phase Clinical trials
Additional remarks Momenteel is er een fase 1-3 studie in voorbereiding. SPC Lucentis verloopt op 23 juli 2022.

Therapeutic value

Therapeutic value Possible equal value

This assessment does not indicate any potential inclusion in the package.

Expected patient volume per year

Patient volume

Market share is generally not included unless otherwise stated.

Expected cost per patient per year

Potential total cost per year

Off label use

Off label use Unknown

Indication extension

Indication extensions Unknown

Other information