Expand all sections

Adalimumab

Cyltezo

Extended indication RA, polyarticular juvenile idiopathic arthritis, active psoriatic arthritis, active ankylosing spond
Therapeutic value Possible equal value
Total cost 3,000,000.00

Product

Active substance Adalimumab
Domain Chronic immune diseases
Main indication Rheumatism
Extended indication RA, polyarticular juvenile idiopathic arthritis, active psoriatic arthritis, active ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis
Proprietary name Cyltezo
Manufacturer Boehringer Ingelheim
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)
Additional remarks Biosimilar alternatief voor Humira.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date January 2017
Expected Registration November 2017
Orphan drug No
Additional remarks Geregistreerd in november 2017.

Therapeutic value

Therapeutic value Possible equal value
Duration of treatment continuous
Frequency of administration 2 times a month
Dosage per administration 40 mg
Additional remarks Toediening 1 maal per 2 weken

Expected patient volume per year

Patient volume

100 - 300

Market share is generally not included unless otherwise stated.
Additional remarks Biosimilar dus deel van de bestaande patienten die op het origineel staan (Humira).

Expected cost per patient per year

Cost < 15,000.00
Additional remarks Als het patent verloopt van origineel (Humira) medio 2018 is de verwachting dat de prijs reduceerd. Kosten Humira vooralsnog pppj: 15.000

Potential total cost per year

Total cost

3,000,000.00

This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year.

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.