Tocilizumab

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	Registration application pending

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)
Mechanism of action	Interleukin inhibitor
Budgetting framework	Intermural (MSZ)

Registration route	Centralised (EMA)
Submission date	August 2022
Expected Registration	August 2023
Orphan drug	No
Registration phase	Registration application pending
Additional remarks	SPC RoActemra verloopt op 6 juni 2020. Er zijn 2 indieningen voor Tocilizumab biosimilars geweest bij de EMA 1 in augustus en 1 in september.

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.