Certolizumab Pegol

Therapeutic Certolizumab Pegol ADC from the original Cimzia® commercial drug.

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TNF alpha
Antibody Fab'fragment
200 mg/mL
8 mg
-80 °C
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Cimzia® / Certolizumab Pegol Reference Product

Drug nameCimzia®
INNCertolizumab Pegol
API typeCertolizumab pegol is a recombinant, humanised antibody Fab' fragment (ADC) against tumour necrosis
factor alpha (TNFα) expressed in Escherichia coli and conjugated to polyethylene glycol (PEG).
Pharmacotherapeutic group
Immunosuppressants, Tumour Necrosis Factor alpha (TNF-α) inhibitors.
ATC code
Target of antibody
TNF alpha
General functionCertolizumab Pegol, in combination with methotrexate (MTX), is indicated for the treatment of moderate to severe, active rheumatoid arthritis (RA) in adult patients when the response to disease-modifying antirheumatic drugs (DMARDs) including MTX, has been inadequate. Cimzia can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate. is also indicated for the treatment of severe, active and progressive RA in adults not previously treated with MTX or other DMARDs.
Short description
Pharmacodynamic properties
(Mechanism of action; Source EMA document)
Certolizumab Pegol has a high affinity for human TNFα and binds with a dissociation constant (KD) of 90 pM.
TNFα is a key pro-inflammatory cytokine with a central role in inflammatory processes. Certolizumab Pegol selectively neutralises TNFα (IC90 of 4 ng/ml for inhibition of human TNFα in the in vitro L929 murine fibrosarcoma cytotoxicity assay) but does not neutralise lymphotoxin α (TNFβ). Certolizumab Pegol was shown to neutralise membrane associated and soluble human TNFα in a dose-dependent manner. Incubation of monocytes with Cimzia resulted in a dose-dependent inhibition of lipopolysaccharide (LPS)-induced TNFα and IL1β production in human monocytes.
Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document)Certolizumab Pegol does not contain a fragment crystallisable (Fc) region, which is normally present in a complete antibody and therefore does not fix complement or cause antibody-dependent cell-mediated cytotoxicity in vitro. It does not induce apoptosis in vitro in human peripheral blood-derived monocytes or lymphocytes, or neutrophil degranulation.
Original license holder
UCB Pharma S.A.
Allée de la Recherche 60
B-1070 Bruxelles
Marketing authorisation numbers
Marketing authorisation holder
UCB Pharma S.A.
Allée de la Recherche 60
B-1070 Bruxelles
Name of the manufacturer of the biological active substance
UCB Farchim SA
Zone Industrielle de Planchy d’Avau
Chemin de Croix Blanche 10
CH-1630 Bulle
Name and address of the manufacturer(s) responsible for batch releaseUCB Pharma S.A.
Chemin du Foriest
B-1420 Braine l'Alleud
Max shelf life
24 months
Storage conditions
2°C – 8°C
List of excipients
Sodium acetate
Sodium chloride
Water for injections