Therapeutic PD-1-antibody from the original Opdivo® commercial drug targeting the PD-1-antigen, also referred to as Opdivo® or nivolumab antibody. Research-relevant quantities are available as licence-free consumable in aliquoted or diluted variant. Therapeutic monoclonal antibodies can be used from researchers in in vitro and in vivo experiments, biosimilar developers can order different batches at the same time.
Easy Access
Easy to order as license-free research consumable
Multiple batches
Up to 10 batches of original drugs for examining batch-to-batch variations
Reduce costs
Up to 80% less compared to the original pharmaceutical price
Prompt delivery
Shipment within days worldwide according to GDP-standards
Documented origin
Information on batch, registration number, expiry date, GDP-compliant pedigree
What our clients say
Anjan Selz
Vice President
Head of Biosimilars EMEA
”Evidentic can supply different batches of reference products for precilinical research.The quick access to the on-stock batches allows for adhoc ordering, keeps costs down and makes a headstart possible!”
Thibault Jonckheere
CEO
“Evidentic is a new source of cost-efficient therapeutic mAbs for our immonassays. And easy to order!”
Tom H. Jin, M.D.
Director of Process Development
“We develop innovative and biosimilar mAbs for a global market. Evidentic’s aRMPs are a great source of cost-efficient reference products for our research and development program.”
Prof. Dr. Henning von Horsten
Life Science Engineering, HTW Berlin
“Evidentic gives rapid access to originator biologics and different batches. For biosimilar developers and regulators, it will shorten the time to gauge the analytical acceptance range for multiple CQAs of biotherapeutics.”
Nivolumab / Opdivo
Product Reference
| 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 | |
| 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. Combined nivolumab (anti-PD-1) and ipilimumab (anti-CTLA-4) mediated inhibition results in improved anti-tumour responses in metastatic melanoma. In murine syngeneic tumour models, dual blockade of PD-1 and CTLA-4 resulted in synergistic anti-tumour activity. |
| Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document) | |
| Original license holder | |
| Marketing authorisation numbers | EU/1/15/1014/001 - 002 |
| Marketing authorisation holder | Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH United Kingdom |
| Name of the manufacturer of the biological active substance | Bristol-Myers Squibb Company 6000 Thompson Road East Syracuse, New York 13057 USA Lonza Biologics, Inc. 101 International Drive Portsmouth, New Hampshire 03801 USA Samsung Biologics Co. Ltd. 125, Cheomdan-daero Yeonsu-gu, Incheon, 21987 Korea |
| Name and address of the manufacturer(s) responsible for batch release | Bristol-Myers Squibb S.r.l. Loc. Fontana del Ceraso 03012 Anagni (FR) Italy |
| Max shelf life | 24 months |
| Storage conditions | 2°C – 8°C |
| List of excipients | Sodium citrate dihydrate |
