Tafasitamab

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 remarks	Dihydroorotate dehydrogenase inhibitors

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

Therapeutic value	Possible equal value

Patiëntvolume is niet van toepassing bij generieke geneesmiddelen of biosimilars.

Horizonscan vermeldt geen prijsinformatie van generieke geneesmiddelen of biosimilars om het eventueel beïnvloeden van de markt te voorkomen.

Horizonscan vermeldt geen prijsinformatie van generieke geneesmiddelen of biosimilars om het eventueel beïnvloeden van de markt te voorkomen.

There is currently nothing known about off label use.

There is currently nothing known about indication extensions.

There is currently no futher information available.