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 BS
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
Route of administration Unknown
Therapeutical formulation Unknown
Budgetting framework Unknown

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Particularity Unknown
ATMP Unknown
Submission date November 2019
Expected Registration February 2021
Orphan drug Unknown
Registration phase Registered
Additional remarks SPC is inmiddels verlopen.

Therapeutic value

Therapeutic value Possible equal value

This assessment does not indicate any potential inclusion in the package.

Expected patient volume per year

Patient volume

Market share is generally not included unless otherwise stated.

Expected cost per patient per year

Potential total cost per year

Off label use

Off label use Unknown

Indication extension

Indication extensions Unknown

Other information