Drug name | Flixabi® | | | |
INN | Infliximab biosimilar | | | |
API type | Infliximab is a chimeric human-murine IgG1 monoclonal antibody produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology. | | | |
Pharmacotherapeutic group | Immunosuppressants, tumour necrosis factor alpha (TNFα) inhibitors | | | |
ATC code | L04AB02 | | | |
Target of antibody | IgG1 | | | |
General function | Infliximab can be used to treat Rheumatoid arthritis, Paediatric and adult Crohn’s disease,Paediatric and adult Ulcerative colitis, Ankylosing spondylitis, Psoriatic arthritis and Psoriasis. | | | |
Short description | | | | |
Pharmacodynamic properties
(Mechanism of action; Source EMA document)
| Infliximab is a chimeric human-murine monoclonal antibody that binds with high affinity to both soluble and transmembrane forms of TNFα but not to lymphotoxin α (TNFß). | | | |
Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document) | Infliximab inhibits the functional activity of TNFα in a wide variety of in vitro bioassays. Infliximab prevented disease in transgenic mice that develop polyarthritis as a result of constitutive expression of human TNFα and when administered after disease onset, it allowed eroded joints to heal. In vivo, infliximab rapidly forms stable complexes with human TNFα, a process that parallels the loss of TNFα bioactivity. | | | |
Original license holder | | | | |
Marketing authorisation numbers | EU/1/16/1106/001-005 | | | |
Marketing authorisation holder | Samsung Bioepis NL B.V.
Olof Palmestraat 10
2616 LR Delft
The Netherlands | | | |
Name of the manufacturer of the biological active substance | FUJIFILM Diosynth Biotechnologies Denmark ApS
Biotek Allé 1,
Hillerød, 3400,
Denmark
Samsung BioLogics Co., Ltd.
300, Songdo bio-daero
Yeonsu-gu, Incheon City, 21987,
Korea, Republic of | | | |
Name and address of the manufacturer(s) responsible for batch release | Biogen Netherlands B.V.
Prins Mauritslaan 13,
1171 LP, Badhoevedorp
Netherlands
Samsung Bioepis NL B.V.
Olof Palmestraat 10
2616 LR Delft
The Netherlands | | | |
Max shelf life | 48 months | | | |
Storage conditions | 2°C – 8°C | | | |
List of excipients | Sucrose
Polysorbate 80
Monobasic sodium phosphate monohydrate (for pH-adjustment)
Dibasic sodium phosphate heptahydrate (for pH-adjustment) | | | |