Nivolumab
Therapeutic Nivolumab antibody from the original Opdivo® commercial drug.
Reference Standard as Aliquots
Opdivo®
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Product Batch | Therapeutic Expiry Date
| Brand & Origin
| Amount per Aliquot | Select Quantity | Discount | Price per Aliquot
| |
|---|---|---|---|---|---|---|---|
2018.08 |
Opdivo® DE |
2 mg |
Unit: aliquot(s) |
316,00 €
/aliquot
|
|||
2018.10 |
Opdivo® DE |
2 mg |
Unit: aliquot(s) |
316,00 €
/aliquot
|
|||
2018.02 |
Opdivo® DE |
2 mg |
Unit: aliquot(s) |
316,00 €
/aliquot
|
|||
2019.01 |
Opdivo® DE |
2 mg |
Unit: aliquot(s) |
316,00 €
/aliquot
|
|||
2020.09 |
Opdivo® DE |
2 mg |
Unit: aliquot(s) |
316,00 €
/aliquot
|
|||
2020.11 |
Opdivo® DE |
2 mg |
Unit: aliquot(s) |
316,00 €
/aliquot
|
|||
2027.06 |
Opdivo® DE |
2 mg |
Unit: aliquot(s) |
237,00 €/aliquot
|
Biosimilars as Aliquots
Access Batch Specific Analytical Information
Evidentic’s Analytical Data Service includes a comprehensive array of methods to support the drug development process, including structure, aggregation, degree of isomerization, and N-glycans identification of the active pharmaceutical ingredient (API).
Product Information
Here you will find the product information for the reference product.
Opdivo® / Nivolumab Reference Product
| Drug name | Opdivo® |
| INN | Nivolumab |
| API type | Nivolumab is produced in Chinese hamster ovary cells by recombinant DNA technology |
| Pharmacotherapeutic group | Antineoplastic agents, monoclonal antibodies |
| ATC code | L01XC17 |
| Target of antibody | PD-1; Synonyms: CD279, PD1, SLEB2, hPD-1, hPD-l, Ly101, Pdc1 |
| General function | Nivolumab, is a monoclonal antibody, a type of protein that has been designed to attach to a receptor (target) called PD-1 found on cells of the immune system called T cells. Cancer cells can produce proteins (PD-L1 and PD-L2) that attach to this receptor and switch off the activity of the T cells, preventing them from attacking the cancer. By attaching to the receptor, nivolumab prevents PD-L1 and PD-L2 from switching off the T cells, thereby increasing the ability of the immune system to kill cancer cells. |
| Short description | |
| Pharmacodynamic properties (Mechanism of action; Source EMA document) | Nivolumab is a human immunoglobulin G4 (IgG4) monoclonal antibody (HuMAb), which binds to the programmed death-1 (PD-1) receptor and blocks its interaction with PD-L1 and PD-L2. The PD-1 receptor is a negative regulator of T-cell activity that has been shown to be involved in the control of T-cell immune responses. Engagement of PD-1 with the ligands PD-L1 and PD-L2, which are expressed in antigen-presenting cells and may be expressed by tumours or other cells in the tumour microenvironment, results in inhibition of T-cell proliferation and cytokine secretion. Nivolumab potentiates T-cell responses, including anti-tumour responses, through blockade of PD-1 binding to PD-L1 and PD-L2 ligands. In syngeneic mouse models, blocking PD-1 activity resulted in decreased tumour growth. |
| Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document) | Nivolumab is an antineoplastic agent. Combined nivolumab (anti-PD-1) and ipilimumab (anti-CTLA-4) mediated inhibition results in improved anti-tumor responses in metastatic melanoma. In murine syngeneic tumor models, dual blockade of PD-1 and CTLA-4 resulted in synergistic anti-tumor activity. |
| Original license holder | Bristol-Myers Squibb Company USA |
| Marketing authorisation numbers | EU/1/15/1014/001 - 003 |
| Marketing authorisation holder | Bristol-Myers Squibb Pharma EEIG Plaza 254 Blanchardstown Corporate Park 2 Dublin 15, D15 T867 Ireland |
| Name of the manufacturer of the biological active substance | Bristol-Myers Squibb Company 6000 Thompson Road East Syracuse, New York 13057 USA Swords Laboratories t/a Bristol-Myers Squibb Cruiserath Biologics Cruiserath Road, Mulhuddart Dublin 15, D15 H6EF Ireland |
| Name and address of the manufacturer(s) responsible for batch release | Swords Laboratories t/a Bristol-Myers Squibb Cruiserath Biologics Cruiserath Road, Mulhuddart Dublin 15, D15 H6EF Ireland |
| Max shelf life | 36 months |
| Storage conditions | 2°C – 8°C |
| List of excipients | Sodium citrate dihydrate Sodium chloride Mannitol (E421) Pentetic acid (diethylenetriaminepentaacetic acid) Polysorbate 80 (E433) Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) |
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