Eculizumab

Active substance
Eculizumab
Domain
Cardiovascular diseases
Reason of inclusion in Horizonscan Geneesmiddelen
Biosimilar
Main indication
Other non-oncological hematological medications
Extended indication
Paroxysmal nocturnal haemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS).

1. Product

Current proprietary name
Soliris (Alexion)
Proprietary name
ABP 959
Manufacturer
Amgen
Mechanism of action
Immunosuppression

2. Registration

Registration route
Centralised (EMA)
Orphan drug
Yes
Registration phase
Clinical trials
Additional comments
Momenteel loopt er een fase III studie (EudraCT Number: 2017-001418-27). SPC Soliris verloopt op 30-04-2020.

3. Therapeutic value

Therapeutic value
Potential equal value
Duration of treatment
Not found

4. Expected patient volume per year

Patiëntvolume is niet van toepassing bij generieke geneesmiddelen of biosimilars.

5. Expected cost per patient per year

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

6. Potential total cost per year

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

7. Off label use

There is currently nothing known about off label use.

8. Indication extension

There is currently nothing known about indication extensions.

9. Other information

There is currently no futher information available.