Cetuximab

Name: Cetuximab G023GS
SKU: 08002234_G023GS
Price: 319.00 EUR
Availability: InStock

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 from
Cetuximab 212882	EGFR	Monoclonal Antibody	Erbitux®	5 mg/mL	–	2 mg	-80°C	11/2019	169,20 €	view product Max: 10 Min: 3 Step: 1
Cetuximab 212884	EGFR	Monoclonal Antibody	Erbitux®	5 mg/mL	–	2 mg	-80°C	01/2020	169,20 €	view product Max: 10 Min: 3 Step: 1
Cetuximab 238081	EGFR	Monoclonal Antibody	Erbitux®	5 mg/mL	–	2 mg	-80°C	05/2021	169,20 €	view product Max: 10 Min: 3 Step: 1
Cetuximab 244682	EGFR	Monoclonal Antibody	Erbitux®	5 mg/mL	–	5 mg	-80°C	09/2021	160,20 €	view product Max: 10 Min: 3 Step: 1
Cetuximab 248033	EGFR	Monoclonal Antibody	Erbitux®	5 mg/mL	–	2 mg	-80°C	11/2021	169,20 €	view product Max: 10 Min: 3 Step: 1
Cetuximab G023GS	EGFR	Monoclonal Antibody	Erbitux®	5 mg/mL	–	5 mg	-80°C	07/2027	319,00 €	view product Max: 3 Min: 1 Step: 1

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Erbitux® / Cetuximab Reference Product

Drug name	Erbitux®
INN	Cetuximab
API type	Cetuximab 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 function	Cetuximab 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 release	Merck 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