Therapeutic Abatacept antibody from the original Orencia® commercial drug.

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Fusion protein
25 mg/mL
5 mg
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Orencia® / Abatacept Reference Product

Drug nameOrencia®
API typeAbatacept is a fusion protein that consists of the extracellular domain of human cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) linked to a modified Fc portion of human immunoglobulin G1 (IgG1). Abatacept is produced by recombinant DNA technology in Chinese hamster ovary cells.
Pharmacotherapeutic group
Immunosuppressants, selective immunosuppressants.
ATC code
Target of antibody
TNF alpha
General functionAbatacept, in combination with methotrexate, is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who responded inadequately to previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) including methotrexate (MTX) or a tumour necrosis factor (TNF)-alpha inhibitor. It is also indicated for the treatment of highly active and progressive disease in adult patients with rheumatoid arthritis not previously treated with methotrexate.
Short description
Pharmacodynamic properties
(Mechanism of action; Source EMA document)
Abatacept selectively modulates a key costimulatory signal required for full activation of T lymphocytes expressing CD28. Full activation of T lymphocytes requires two signals provided by antigen presenting cells: recognition of a specific antigen by a T cell receptor (signal 1) and a second, costimulatory signal. A major costimulatory pathway involves the binding of CD80 and CD86 molecules on the surface of antigen presenting cells to the CD28 receptor on T lymphocytes (signal 2). Abatacept selectively inhibits this costimulatory pathway by specifically binding to CD80 and CD86. Studies indicate that naive T lymphocyte responses are more affected by abatacept than memory T lymphocyte responses.
Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document)Dose-dependent reductions were observed with abatacept in serum levels of soluble interleukin-2 receptor, a marker of T lymphocyte activation; serum interleukin-6, a product of activated synovial macrophages and fibroblast-like synoviocytes in rheumatoid arthritis; rheumatoid factor, an autoantibody produced by plasma cells; and C-reactive protein, an acute-phase reactant of inflammation. In addition, serum levels of matrix metalloproteinase-3, which produces cartilage destruction and tissue remodelling, were decreased. Reductions in serum TNFα were also observed.
Original license holder
Bristol-Myers Squibb Pharma EEIG
Plaza 254
Blanchardstown Corporate Park 2
Dublin 15, D15 T867
Marketing authorisation numbers
Marketing authorisation holder
Bristol-Myers Squibb Pharma EEIG
Plaza 254
Blanchardstown Corporate Park 2
Dublin 15, D15 T867
Name of the manufacturer of the biological active substance
Bristol-Myers Squibb Co.
38 Jackson Road
Devens, MA 01434
Name and address of the manufacturer(s) responsible for batch releaseCATALENT ANAGNI S.R.L.
Loc. Fontana del Ceraso snc
Strada Provinciale 12 Casilina, 41
03012 Anagni (FR)

Swords Laboratories t/a Bristol-Myers Squibb Cruiserath Biologics
Cruiserath Road, Mulhuddart
Dublin 15
Max shelf life
3 years
Storage conditions
2°C – 8°C
List of excipients
Sodium dihydrogen phosphate monohydrate
Sodium chloride