Adalimumab

Therapeutic Adalimumab antibody from the original Humira® commercial drug

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Humira® / Adalimumab Reference Product

Drug nameHumira®
INNAdalimumab
API typeAdalimumab is a recombinant human monoclonal antibody expressed in Chinese Hamster Ovary cells.
Pharmacotherapeutic group
Immunosuppressants, Tumour Necrosis Factor alpha (TNF-α) inhibitors.
ATC code
L04AB04
Target of antibody
TNF alpha
General functionAdalimumab binds specifically to TNF and neutralizes the biological function of TNF by blocking its
interaction with the p55 and p75 cell surface TNF receptors.
Adalimumab also modulates biological responses that are induced or regulated by TNF, including
changes in the levels of adhesion molecules responsible for leukocyte migration (ELAM-1, VCAM-1,
and ICAM-1 with an IC50 of0.1-0.2 nM).
Short description
Pharmacodynamic properties
(Mechanism of action; Source EMA document)
Adalimumab binds specifically to TNF and neutralizes the biological function of TNF by blocking its interaction with the p55 and p75 cell surface TNF receptors.

Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document)Adalimumab also modulates biological responses that are induced or regulated by TNF, including changes in the levels of adhesion molecules responsible for leukocyte migration (ELAM-1, VCAM-1, and ICAM-1 with an IC50 of 0.1-0.2 nM).
Original license holder
AbbVie Biotechnology GmbH Knollstrasse 67061 Ludwigshafen Germany
Marketing authorisation numbers
EU/1/03/256/022
Marketing authorisation holder
AbbVie Ltd
Maidenhead
SL6 4UB
United Kingdom
Name of the manufacturer of the biological active substance
AbbVie Bioresearch Center
100 Research Drive
Worcester
MA 01605
USA
Name and address of the manufacturer(s) responsible for batch releaseAbbVie Biotechnology GmbH
Knollstrasse
67061 Ludwigshafen
Germany
Max shelf life
24 months
Storage conditions
2°C – 8°C
List of excipients
Mannitol
Polysorbate 80
Evidentic Support
+49 (0) 30 959 99 8831

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