Extended indication The treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.
Therapeutic value Possible equal value
Registration phase Registered

Product

Active substance Insulin aspart
Domain Metabolism and Endocrinology
Reason of inclusion Biosimilar
Main indication Diabetes
Extended indication The treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.
Current proprietary name NovoRapid (Novo Nordisk)
Proprietary name Kixelle
Manufacturer Mylan
Mechanism of action Receptor agonist

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date November 2019
Expected Registration February 2021
Registration phase Registered
Additional comments SPC is inmiddels verlopen.

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.