Extended indication Pirfenidone AET is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fi
Therapeutic value Possible equal value
Registration phase Positive CHMP opinion

Product

Active substance Pirfenidone
Domain Lung diseases
Reason of inclusion Generic
Extended indication Pirfenidone AET is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF).
Current proprietary name Esbriet (Roche)
Already available biosimilars / generics geen
Proprietary name Pirfenidone AET
Route of administration Oral
Budgetting framework Extramural (GVS)
Additional comments Collagen inhibitors; Cytokine inhibitors Portfoliohouder en fabrikant is AET.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date May 2021
Expected Registration June 2022
Orphan drug No
Registration phase Positive CHMP opinion
Additional comments Vele patenten geldig, de komende jaren nog allemaal van kracht. Positieve CHMP-opinie verkregen in april 2022.

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.