Therapeutic Cetuximab antibody from the original Erbitux® commercial drug.
Product batch
| Expiry date
| Brand & Origin
| Price
| 1. Select quantity range | 2. Your quantity | |
|---|---|---|---|---|---|---|
2019.11 |
Erbitux® DE |
98,50 €
/mg
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mg |
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2020.01 |
Erbitux® DE |
98,50 €
/mg
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Select quantity:
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mg |
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2021.05 |
Erbitux® DE |
98,50 €
/mg
|
Select quantity:
|
mg |
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2021.09 |
Erbitux® DE |
65,80 €
/mg
|
Select quantity:
|
mg |
||
2021.11 |
Erbitux® DE |
98,50 €
/mg
|
Select quantity:
|
mg |
Evidentic’s analytical service includes a comprehensive array of methods to support the drug development process, including, for example, structure, aggregation, degree of isomerization and N-glycans identification of the active pharmaceutical ingredient (API).
Here you will find the product information for the 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 |
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