Amivantamab
Therapeutic Amivantamab antibody from the original Rybrevant® commercial drug.
Reference Standard as Aliquots
Product Batch | Therapeutic Expiry Date
| Brand & Origin
| Amount per Aliquot
| Select Quantity | Discount | Price per Aliquot
| |
|---|---|---|---|---|---|---|---|
2027.04 |
Rybrevant® DE |
7 mg |
Unit: aliquot(s) |
282,00 €/aliquot
|
Biosimilars as Aliquots
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Product Information
Here you will find the product information for the reference product.
Rybrevant® / Amivantamab Reference Product
| Drug name | Rybrevant® |
| INN | Amivantamab |
| API type | Bispecific antibody |
| Pharmacotherapeutic group | Monoclonal antibodies and antibody-drug conjugates |
| ATC code | L01FX18 |
| Target of antibody | EGFR, MET |
| General function | |
| Short description | Amivantamab is a fully-human Immunoglobulin G1 (IgG1)-based bispecific antibody directed against the epidermal growth factor (EGF) and mesenchymal-epidermal transition (MET) receptors, produced by a mammalian cell line (Chinese Hamster Ovary [CHO]) using recombinant DNA technology. |
| Pharmacodynamic properties (Mechanism of action; Source EMA document) | Amivantamab is a low-fucose, fully-human IgG1-based EGFR-MET bispecific antibody with immune cell-directing activity that targets tumours with activating EGFR Exon 20 insertion mutations. Amivantamab binds to the extracellular domains of EGFR and MET. Amivantamab disrupts EGFR and MET signalling functions through blocking ligand binding and enhancing degradation of EGFR and MET, thereby preventing tumour growth and progression. The presence of EGFR and MET on the surface of tumour cells also allows for targeting of these cells for destruction by immune effector cells, such as natural killer cells and macrophages, through antibody-dependent cellular cytotoxicity (ADCC) and trogocytosis mechanisms, respectively. |
| Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document) | Amivantamab decreased serum albumin concentration, a pharmacodynamic effect of MET inhibition; thereafter, albumin concentration stabilised for the remainder of amivantamab treatment. |
| Original license holder | Janssen-Cilag International NV Turnhoutseweg 30 B-2340 Beerse Belgium |
| Marketing authorisation numbers | EU/1/21/1594/001 |
| Marketing authorisation holder | Janssen-Cilag International NV Turnhoutseweg 30 B-2340 Beerse Belgium |
| Name of the manufacturer of the biological active substance | Janssen Sciences Ireland UC Barnahely Ringaskiddy, Co. Cork Ireland |
| Name and address of the manufacturer(s) responsible for batch release | Janssen Biologics B.V. Einsteinweg 101 2333 CB Leiden The Netherlands |
| Max shelf life | 24 months |
| Storage conditions | 2°C – 8°C |
| List of excipients | Ethylenediaminetetraacetic acid (EDTA) disodium salt dihydrate L-Histidine L-Histidine hydrochloride monohydrate L-Methionine Polysorbate 80 (E433) Sucrose Water for injections |
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