Extended indication Rheumatoid arthritis (RA), giant lymph node hyperplasia (Castlesman’s disease), polyarticular idioat
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

Registration route Centralised (EMA)
Submission date August 2022
Expected Registration August 2023
Orphan drug No
Registration phase Registration application pending
Additional comments 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

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.