Ranibizumab

Active substance Ranibizumab
Domain Neurological disorders
Reason of inclusion in Horizonscan Geneesmiddelen Biosimilar
Main indication Eye disorders
Extended indication Wet age-related macular degeneration (AMD).

Product

Current proprietary name Lucentis (Roche)
Proprietary name FYB201
Manufacturer Formycon AG
Mechanism of action Angiogenesis inhibitor
Budgetting framework Intermural (MSZ)
Additional comments Dit betreft 1 van de vier biosimilars voor ranibizumab die is opgenomen in de Horizonscan.

Registration

Registration route Centralised (EMA)
Orphan drug No
Registration phase Clinical trials
Additional comments Fase 3 studie afgerond in juli 2018 (NCT02611778). SPC Lucentis verloopt op 23 januari 2022.

Therapeutic value

Therapeutic value Potential equal value
Duration of treatment Not found

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.