Extended indication Volwassenen met 'relapsing remitting' multipele sclerose (RRMS).
Therapeutic value Possible equal value
Registration phase Registered

Product

Active substance Teriflunomide
Domain Neurological disorders
Reason of inclusion Generic
Main indication Multiple sclerosis
Extended indication Volwassenen met 'relapsing remitting' multipele sclerose (RRMS).
Current proprietary name Aubagio (Genzyme)
Already available biosimilars / generics geen
Proprietary name Teriflunomide Mylan
Manufacturer Mylan
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Extramural (GVS)
Additional comments Dihydroorotate dehydrogenase inhibitors

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date September 2021
Expected Registration November 2022
Registration phase Registered
Additional comments Per september 2022 positieve opinie. SPC verleend en van kracht per 4 april 2022 en verloopt per 03 april 2027.

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.