Cetuximab

Therapeutic Cetuximab antibody from the original Erbitux® commercial drug.

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Product
Batch

Antigen
Molecular Class
Drug Brand
Product Concentration
CoA
Quantity per vial
Storage Temperature
Expiry Date
Price
EGFR
Monoclonal Antibody
Erbitux®
5 mg/mL
2 mg
-80°C
11/2019
196,00 
view product
Max: 10
Min: 2
Step: 1
EGFR
Monoclonal Antibody
Erbitux®
5 mg/mL
2 mg
-80°C
01/2020
196,00 
view product
Max: 10
Min: 2
Step: 1
EGFR
Monoclonal Antibody
Erbitux®
5 mg/mL
2 mg
-80°C
05/2021
196,00 
view product
Max: 10
Min: 2
Step: 1
EGFR
Monoclonal Antibody
Erbitux®
5 mg/mL
5 mg
-80°C
09/2021
421,00 
view product
Max: 10
Min: 1
Step: 1
EGFR
Monoclonal Antibody
Erbitux®
5 mg/mL
2 mg
-80°C
11/2021
196,00 
view product
Max: 10
Min: 2
Step: 1

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Erbitux® / Cetuximab Reference Product

Drug nameErbitux®
INNCetuximab
API typeCetuximab is a chimeric monoclonal IgG1antibody produced in a mammalian cell line (Sp2/0) by recombinant DNA technology
Pharmacotherapeutic group
Antineoplastic agents, monoclonal antibodie
ATC code
L01XC06
Target of antibody
EGFR
General functionCetuximab is indicated for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, RAS wild-type metastatic colorectal cancer and for the treatment of patients with squamous cell cancer of the head and neck.
Short description
Pharmacodynamic properties
(Mechanism of action; Source EMA document)
Cetuximab is a chimeric monoclonal IgG1 antibody that is specifically directed against the epidermal growth factor receptor (EGFR).
EGFR signalling pathways are involved in the control of cell survival, cell cycle progression, angiogenesis, cell migration and cellular invasion/metastasis.
Cetuximab binds to the EGFR with an affinity that is approximately 5- to 10-fold higher than that of endogenous ligands. Cetuximab blocks binding of endogenous EGFR ligands resulting in inhibition of the function of the receptor. It further induces the internalisation of EGFR, which can lead to downregulation of EGFR. Cetuximab also targets cytotoxic immune effector cells towards EGFRexpressing tumour cells (antibody dependent cell-mediated cytotoxicity, ADCC).
Cetuximab does not bind to other receptors belonging to the HER family. The protein product of the proto-oncogene RAS (rat sarcoma) is a central down-stream signal transducer of EGFR. In tumours, activation of RAS by EGFR contributes to EGFR-mediated increased proliferation, survival and the production of pro-angiogenic factors.
RAS is one of the most frequently activated family of oncogenes in human cancers. Mutations of RAS genes at certain hot-spots on exons 2, 3 and 4 result in constitutive activation of RAS proteins independently of EGFR signaling.
Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document)In both in vitro and in vivo assays, cetuximab inhibits the proliferation and induces apoptosis of human tumour cells that express EGFR. In vitro cetuximab inhibits the production of angiogenic factors by tumour cells and blocks endothelial cell migration. In vivo cetuximab inhibits expression of angiogenic factors by tumour cells and causes a reduction in tumour neo-vascularisation and metastasis.
Original license holder
Merck Europe B.V.
Gustav Mahlerplein 102
1082 MA Amsterdam
The Netherlands
Marketing authorisation numbers
EU/1/04/281/003
EU/1/04/281/005
Marketing authorisation holder
Merck Europe B.V.
Gustav Mahlerplein 102
1082 MA Amsterdam
The Netherlands
Name of the manufacturer of the biological active substance
Merck KGaA
Frankfurter Straße 250
64293 Darmstadt
Germany

Boehringer Ingelheim Pharma GmbH & Co KG
Birkendorfer Str. 65
88397 Biberach
Germany
Name and address of the manufacturer(s) responsible for batch releaseMerck Healthcare KGaA
Frankfurter Straße 250
64293 Darmstadt
Germany
Max shelf life
48 months
Storage conditions
2°C – 8°C
List of excipients
Sodium chloride
Glycine
Polysorbate 80
Citric acid monohydrate
Sodium hydroxide
Water for injections
Evidentic Support
+49 (0) 30 959 99 8831

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