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Adalimumab

Imraldi

Extended indication RA, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, pediatri
Therapeutic value Possible equal value
Total cost 10,500,000.00

Product

Active substance Adalimumab
Domain Chronic immune diseases
Main indication Skin diseases
Extended indication RA, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, pediatric plaque psoriasis, adult and adolescent hidradenitis suppurativa, Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis, uveitis
Proprietary name Imraldi
Manufacturer samsung
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)
Additional remarks Biosimilar alternatief voor Humira.

Registration

Registration route Centralised (EMA)
Expected Registration August 2017
Orphan drug No
Additional remarks Geregistreerd in augustus 2017.

Therapeutic value

Current treatment options Adalimumab (Humira)
Therapeutic value Possible equal value
Substantiation Biosimilar
Duration of treatment continuous
Frequency of administration 1 times a month
Dosage per administration 40 mg
References Weinblatt et al, Arthritis Rheumatol. 2017 Sep 26. doi: 10.1002/art.40336; Jamshidi et al, Arthritis Res Ther. 2017 Jul 20;19(1):168. doi: 10.1186/s13075-017-1371-4; Shin et al, J Clin Pharm Ther. 2017 Jul 3. doi: 10.1111/jcpt.12583; Cohen et al, Ann Rheum Dis. 2017 Oct;76(10):1679-1687. doi: 10.1136/annrheumdis-2016-210459; Papp et al. J Am Acad Dermatol. 2017 Jun;76(6):1093-1102. doi: 10.1016/j.jaad.2016.12.014; Park et al, Expert Opin Investig Drugs. 2017 May;26(5):619-624. doi: 10.1080/13543784.2017.1307339; Wynne et al, Expert Opin Investig Drugs. 2016 Dec;25(12):1361-1370. PubMed PMID: 27813422; Kaur et al, Ann Rheum Dis. 2017 Mar;76(3):526-533. doi: 10.1136/annrheumdis-2015-208914. Epub 2016 Jul 27; Hyland et al, Br J Clin Pharmacol. 2016 Oct;82(4):983-93. doi: 10.1111/bcp.13039. Epub 2016 Jul 28; Jani et al, Int J Rheum Dis. 2016 Nov;19(11):1157-1168. doi: 10.1111/1756-185X.12711. Epub 2015 Jul 14.
Additional remarks Toediening 1 maal per 2 weken

Expected patient volume per year

Patient volume

< 1,000

Market share is generally not included unless otherwise stated.
Additional remarks Mogelijk duizenden patiënten, maar altijd op basis van 'switch'. Dit middel is een biosimilar dus het zal voorgeschreven worden aan een deel van de bestaande patiënten die op het origineel staan (Humira). Het feitelijk aantal behandelde patiënten zal geheel afhangen van de prijsonderhandelingen door de universitaire medische centra.

Expected cost per patient per year

Cost 7,000.00 - 14,000.00
Additional remarks Gelijke of minderkosten; het zal geheel afhangen van de onderhandelingen. Als het patent verloopt van origineel (Humira) medio 2018 is de verwachting dat de prijs reduceerd.

Potential total cost per year

Total cost

10,500,000.00

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

Off label use No

Indication extension

Indication extension No

Other information

There is currently no futher information available.