Extended indication Diabetic macular edema
Therapeutic value Possible equal value
Registration phase Registered

Product

Active substance Aflibercept
Domain Neurological disorders
Reason of inclusion Biosimilar BS
Main indication Eye disorders
Extended indication Diabetic macular edema
Current proprietary name Eylea (Bayer)
Proprietary name M-710
Manufacturer Momenta/Mylan
Mechanism of action Angiogenesis inhibitor
Route of administration Unknown
Therapeutical formulation Unknown
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Unknown
Particularity Unknown
ATMP No
Submission date May 2022
Expected Registration September 2023
Orphan drug No
Registration phase Registered
Additional remarks Positieve CHMP-opinie juli 2023. SPC Eylea verloopt op 22 mei 2025.

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