Extended indication Lichte tot matige idiopathische pulmonale fibrose (IPF) bij volwassenen.
Therapeutic value Possible equal value
Registration phase Registration application pending

Product

Active substance Pirfenidone
Domain Lung diseases
Reason of inclusion Generic
Main indication Lung other
Extended indication Lichte tot matige idiopathische pulmonale fibrose (IPF) bij volwassenen.
Current proprietary name Esbriet (Roche)
Already available biosimilars / generics geen
Route of administration Oral
Budgetting framework Extramural (GVS)
Additional comments Collagen inhibitors; Cytokine inhibitors

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date May 2021
Expected Registration May 2022
Orphan drug No
Registration phase Registration application pending
Additional comments Vele patenten geldig, de komende jaren nog allemaal van kracht.

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.