Belatacept drug aliquots can be used for in vitro or in vivo experiments. For biosimilar development, different batches of Belatacept drug can be ordered at the same time. Several other reference drugs are also available.
The drug aliquots are generated by aliquoting (dividing and repackaging) the EU-licensed reference drug.
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Up to 10 batches of original drugs for examining batch-to-batch variations
Up to 80% less compared to the original pharmaceutical price
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Up to 80% less compared to the original pharmaceutical price
| Drug name | Nulojix® |
| INN | Belatacept |
| API type | Belatacept is a fusion protein produced in Chinese hamster ovary cells by recombinant DNA technology. |
| Pharmacotherapeutic group | Immunosuppressants, selective immunosuppressants |
| ATC code | L04AA28 |
| Target of antibody | CD80, CD86 |
| General function | Nulojix is used in adults to prevent the body from rejecting a transplanted kidney. It is used with corticosteroids and a mycophenolic acid (other medicines used to prevent organ rejection). An interleukin-2-receptor-antagonist medicine should also be used with Nulojix during the first week after the kidney transplant. The medicine can only be obtained with a prescription. |
| Short description | |
| Pharmacodynamic properties (Mechanism of action; Source EMA document) | Belatacept binds to CD80 and CD86 on antigen presenting cells. As a result, belatacept blocks CD28 mediated co-stimulation of T cells inhibiting their activation. Activated T cells are the predominant mediators of immunologic response to the transplanted kidney. Belatacept, a modified form of CTLA4-Ig, binds CD80 and CD86 more avidly than the parent CTLA4-Ig molecule from which it is derived. This increased avidity provides a level of immunosuppression that is necessary for preventing immune-mediated allograft failure and dysfunction. |
| Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document) | In a clinical study, approximately 90% saturation of CD86 receptors on the surface of antigenpresenting cells in the peripheral blood was observed following the initial administration of belatacept. During the first month post-transplantation, 85% saturation of CD86 was maintained. Up to month 3 post-transplantation with the recommended dosing regimen, the level of CD86 saturation was maintained at approximately 70% and at month 12, approximately 65%. |
| Original license holder | |
| Marketing authorisation numbers | EU/1/11/694/001-002 |
| 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 – U.S.A. |
| Name and address of the manufacturer(s) responsible for batch release | Swords Laboratories Unlimited Company 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 | Sucrose Sodium dihydrogen phosphate monohydrate Sodium chloride Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) |
Evidentic offers multiple batches of original drug aliquots in low binding Eppendorf tubes for research use only. We provide licence-free drug aliquots with long, short or even “negative shelf life” by storing the products at recommended temperatures (either 2-8°C or -80°C) and ensuring fully functional molecules for research purposes.
Evidentic GmbH
Am Mühlenberg 10
14476 Potsdam | Germany
