Thrombomodulin alfa

Extended indication	Rheumatoid arthritis (RA), giant lymph node hyperplasia (Castlesman’s disease), polyarticular idioathic juvenile arthritis (PJIA) and systemic juvenile idiopathic arthritis (SJIA).
Therapeutic value	Possible equal value
Registration phase	Clinical trials

Product

Active substance	Tocilizumab
Domain	Chronic immune diseases
Reason of inclusion	Biosimilar
Main indication	Rheumatism
Extended indication	Rheumatoid arthritis (RA), giant lymph node hyperplasia (Castlesman’s disease), polyarticular idioathic juvenile arthritis (PJIA) and systemic juvenile idiopathic arthritis (SJIA).
Current proprietary name	RoActemra (Roche)
Proprietary name	LusiNEX
Manufacturer	Mycenax Biotech
Mechanism of action	Interleukin inhibitor

Registration route	Centralised (EMA)
Orphan drug	No
Registration phase	Clinical trials
Additional remarks	Momenteel loopt er een fase 1 studie (NCT03522012). SPC RoActemra verloopt op 6 juni 2020.

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.